OneTouch Verio IQ 022-275Recalls & reported problems

Summary

The FDA's MAUDE database contains 6,035 adverse event reports that list this exact device (DI 00353885008402), received between Nov 18, 2016 and Jul 23, 2024 — classified as 325 injuries, 5,707 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (2,924 reports).

1 other recall cover devices cleared under the same FDA submission (K110637); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 6,035 reports, in the reporter's own words as published by the FDA.

• InjuryJul 23, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON JULY 12, 2024, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT HER ONETOUCH VERIO IQ METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION, SINCE THE PATIENT COULD NOT BE REACHED BY PHONE FOR ADDITIONAL INFORMATION. IT IS UNCLEAR WHEN THE ALLEGED METER INACCURACY BEGAN. THE PATIENT REPORTED OBTAINING WHAT SHE FELT WERE INACCURATE HIGH BLOOD GLUCOSE READINGS OF ¿131 AND 41 MG/DL¿ WITH THE SUBJECT METER ON UNSPECIFIED DATES/TIMES. THE PATIENT MANAGES HER DIABETES WITH A COMBINATION OF INSULIN (HUMULIN R AND HUMULIN N) AND ORAL MEDICATION (METFORMIN). IT WAS NOT REPORTED IF THE PATIENT MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT REPORTED THAT ON (B)(6) 2024, AT 12:00 PM, AFTER THE ALLEGED ISSUE BEGAN, SHE WAS ¿NOT ABLE TO TALK, EVEN RAISE HER HAND OR MOVE¿ FOR ABOUT 30 MINUTES. AT THE ONSET OF THE SYMPTOMS, THE PATIENT REPORTEDLY RECEIVED ASSISTANCE FROM FAMILY WHO TOOK HER TO BED AND PROVIDED APPLE JUICE AND THEN SHE SLEPT. NO OTHER DEVICE WAS USED FOR TESTING. AT THE TIME OF TROUBLESHOOTING

  Patient problems: Dysphasia; Paresis

  MAUDE report 19803521 ↗
• InjuryJul 23, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2024, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT HER ONETOUCH VERIO IQ METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION, SINCE THE PATIENT COULD NOT BE REACHED BY PHONE FOR ADDITIONAL INFORMATION. IT IS UNCLEAR WHEN THE ALLEGED METER INACCURACY BEGAN. THE PATIENT REPORTED OBTAINING WHAT SHE FELT WERE INACCURATE HIGH BLOOD GLUCOSE READINGS OF ¿131 AND 41 MG/DL¿ WITH THE SUBJECT METER ON UNSPECIFIED DATES/TIMES. THE PATIENT MANAGES HER DIABETES WITH A COMBINATION OF INSULIN (HUMULIN R AND HUMULIN N) AND ORAL MEDICATION (METFORMIN). IT WAS NOT REPORTED IF THE PATIENT MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT REPORTED THAT ON (B)(6) 2024, AT 7:30 AM, AFTER THE ALLEGED ISSUE BEGAN, SHE WAS ¿NOT ABLE TO TALK, EVEN RAISE HER HAND OR MOVE¿ FOR ABOUT 30 MINUTES. AT THE ONSET OF THE SYMPTOMS, THE PATIENT REPORTEDLY RECEIVED ASSISTANCE FROM FAMILY WHO TOOK HER TO BED AND PROVIDED APPLE JUICE AND THEN SHE SLEPT. NO OTHER DEVICE WAS USED FOR TESTING. AT THE TIME OF TROUBLESHOOTING, T

  Patient problems: Dysphasia; Paresis

  MAUDE report 19803503 ↗
• InjuryJul 23, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON JULY 12, 2024, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT HER ONETOUCH VERIO IQ METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION, SINCE THE PATIENT COULD NOT BE REACHED BY PHONE FOR ADDITIONAL INFORMATION. IT IS UNCLEAR WHEN THE ALLEGED METER INACCURACY BEGAN. THE PATIENT REPORTED OBTAINING WHAT SHE FELT WERE INACCURATE HIGH BLOOD GLUCOSE READINGS OF ¿131 AND 41 MG/DL¿ WITH THE SUBJECT METER ON UNSPECIFIED DATES/TIMES. THE PATIENT MANAGES HER DIABETES WITH A COMBINATION OF INSULIN (HUMULIN R AND HUMULIN N) AND ORAL MEDICATION (METFORMIN). IT WAS NOT REPORTED IF THE PATIENT MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT REPORTED THAT ON (B)(6) 2024, AT 12:00 PM, AFTER THE ALLEGED ISSUE BEGAN, SHE WAS ¿NOT ABLE TO TALK, EVEN RAISE HER HAND OR MOVE¿ FOR ABOUT 30 MINUTES. AT THE ONSET OF THE SYMPTOMS, THE PATIENT REPORTEDLY RECEIVED ASSISTANCE FROM FAMILY WHO TOOK HER TO BED AND PROVIDED APPLE JUICE AND THEN SHE SLEPT. NO OTHER DEVICE WAS USED FOR TESTING. AT THE TIME OF TROUBLESHOOTING

  Patient problems: Dysphasia; Paresis

  MAUDE report 19803502 ↗
• InjuryJul 23, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON JULY 12, 2024, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT HER ONETOUCH VERIO IQ METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION, SINCE THE PATIENT COULD NOT BE REACHED BY PHONE FOR ADDITIONAL INFORMATION. IT IS UNCLEAR WHEN THE ALLEGED METER INACCURACY BEGAN. THE PATIENT REPORTED OBTAINING WHAT SHE FELT WERE INACCURATE HIGH BLOOD GLUCOSE READINGS OF ¿131 AND 41 MG/DL¿ WITH THE SUBJECT METER ON UNSPECIFIED DATES/TIMES. THE PATIENT MANAGES HER DIABETES WITH A COMBINATION OF INSULIN (HUMULIN R AND HUMULIN N) AND ORAL MEDICATION (METFORMIN). IT WAS NOT REPORTED IF THE PATIENT MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT REPORTED THAT ON (B)(6) 2024, AT 7:30 AM, AFTER THE ALLEGED ISSUE BEGAN, SHE WAS ¿NOT ABLE TO TALK, EVEN RAISE HER HAND OR MOVE¿ FOR ABOUT 30 MINUTES. AT THE ONSET OF THE SYMPTOMS, THE PATIENT REPORTEDLY RECEIVED ASSISTANCE FROM FAMILY WHO TOOK HER TO BED AND PROVIDED APPLE JUICE AND THEN SHE SLEPT. NO OTHER DEVICE WAS USED FOR TESTING. AT THE TIME OF TROUBLESHOOTING,

  Patient problems: Dysphasia; Paresis

  MAUDE report 19802800 ↗
• InjuryJun 4, 2024Power Problem; Power Problem

  ON (B)(6) 2024, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT HIS ONETOUCH VERIO IQ METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT ON (B)(6) 2024, AT 10:00 PM, HE WAS FEELING ¿REALLY BAD AND NAUSEOUS¿. IN RESPONSE TO THE SYMPTOMS, THE PATIENT CLAIMED HE ATTEMPTED TO TEST HIS BLOOD GLUCOSE WITH THE SUBJECT METER BUT WAS UNABLE TO OBTAIN A READING DUE TO THE ALLEGED POWER ISSUE. AS A RESULT, THE PATIENT STATED THAT HE WENT TO THE URGENT CARE CLINIC WHERE HE RECEIVED A BLOOD GLUCOSE RESULT OF ¿532 MG/DL¿ ON THE CLINIC METER AND WAS TREATED WITH 10 UNITS OF ADMELOG INSULIN AND INTRAVENOUS FLUIDS AT 11:00 PM. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME AND THAT THERE WAS NO INDICATION OF MISUSE OF THE DEVICE. THE CCA CONFIRMED THE CORRECT TEST STRIPS WERE BEING USED FOR TESTING. THE CCA NOTED THAT THE PATIENT NO LONGER HAD THE SUBJECT METER AS IT HAD BEEN DISCARDED. A REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY RECEIVED MEDICAL INTERVENTION FOR A

  Patient problems: Hyperglycemia

  MAUDE report 19464767 ↗
• InjuryJun 4, 2024Power Problem; Power Problem

  ON (B)(6) 2024, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT HIS ONE TOUCH VERIO IQ METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT ON (B)(6) 2024, AT 10:00 PM, HE WAS FEELING ¿REALLY BAD AND NAUSEOUS¿. IN RESPONSE TO THE SYMPTOMS, THE PATIENT CLAIMED HE ATTEMPTED TO TEST HIS BLOOD GLUCOSE WITH THE SUBJECT METER BUT WAS UNABLE TO OBTAIN A READING DUE TO THE ALLEGED POWER ISSUE. AS A RESULT, THE PATIENT STATED THAT HE WENT TO THE URGENT CARE CLINIC WHERE HE RECEIVED A BLOOD GLUCOSE RESULT OF ¿532 MG/DL¿ ON THE CLINIC METER AND WAS TREATED WITH 10 UNITS OF ADMELOG INSULIN AND INTRAVENOUS FLUIDS AT 11:00 PM. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME AND THAT THERE WAS NO INDICATION OF MISUSE OF THE DEVICE. THE CCA CONFIRMED THE CORRECT TEST STRIPS WERE BEING USED FOR TESTING. THE CCA NOTED THAT THE PATIENT NO LONGER HAD THE SUBJECT METER AS IT HAD BEEN DISCARDED. A REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY RECEIVED MEDICAL INTERVENTION FOR

  Patient problems: Hyperglycemia

  MAUDE report 19464756 ↗
• InjuryFeb 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON(B)(6) 2024, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT HER ONETOUCH VERIO IQ METER READ INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION, AND ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST AFTER REVIEWING THE CALL RECORDING. IT WAS NOT REPORTED WHEN THE ALLEGED METER INACCURACY BEGAN. THE PATIENT REPORTED OBTAINING WHAT SHE FELT WERE INACCURATE ERRATIC BLOOD GLUCOSE READINGS OF ¿116, 202 AND 50 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT STATED THAT SHE DOES NOT TAKE ANY MEDICATION TO MANAGE HER DIABETES AND DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE REPORTED ISSUE. THE PATIENT STATED THAT ON ONE OCCASION LAST WEEK, AROUND 1 AND A HALF HOURS AFTER OBTAINING THE ¿202 MG/DL¿ READING, SHE EXPERIENCED SYMPTOMS OF ¿DIZZINESS, FELT UNWELL AND FELT ABOUT TO PASS OUT". 10 MINUTES AFTER THE ONSET OF SYMPTOMS, THE PATIENT CLAIMED SHE RE-TESTED HER BLOOD GLUCOSE WITH THE SUBJECT METER AND OBTAINED THE READING OF ¿50 MG/DL¿. THE PATIENT INDICATED THAT SHE TREATED HERSELF WITH SUGAR AND SOUGHT MEDICAL ATTENTION. THE PATIENT REPORTEDLY WAS

  Patient problems: Dizziness; Hypoglycemia; Malaise; Presyncope

  MAUDE report 18727941 ↗
• InjuryFeb 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT HER ONETOUCH VERIO IQ METER READ INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION, AND ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST AFTER REVIEWING THE CALL RECORDING. IT WAS NOT REPORTED WHEN THE ALLEGED METER INACCURACY BEGAN. THE PATIENT REPORTED OBTAINING WHAT SHE FELT WERE INACCURATE ERRATIC BLOOD GLUCOSE READINGS OF ¿116, 202 AND 50 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT STATED THAT SHE DOES NOT TAKE ANY MEDICATION TO MANAGE HER DIABETES AND DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE REPORTED ISSUE. THE PATIENT STATED THAT ON ONE OCCASION LAST WEEK, AROUND 1 AND A HALF HOURS AFTER OBTAINING THE ¿202 MG/DL¿ READING, SHE EXPERIENCED SYMPTOMS OF ¿DIZZINESS, FELT UNWELL AND FELT ABOUT TO PASS OUT". 10 MINUTES AFTER THE ONSET OF SYMPTOMS, THE PATIENT CLAIMED SHE RE-TESTED HER BLOOD GLUCOSE WITH THE SUBJECT METER AND OBTAINED THE READING OF ¿50 MG/DL¿. THE PATIENT INDICATED THAT SHE TREATED HERSELF WITH SUGAR AND SOUGHT MEDICAL ATTENTION. THE PATIENT REPORTEDLY WA

  Patient problems: Dizziness; Hypoglycemia; Malaise; Presyncope

  MAUDE report 18727940 ↗
• InjuryOct 5, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON SEPTEMBER 28, 2023, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT HER ONETOUCH VERIO IQ METER READ INACCURATELY COMPARED TO HER FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN A FEW WEEKS PRIOR TO CONTACTING LFS. THE PATIENT REPORTED OBTAINING ALLEGED INACCURATE READINGS OF ¿600, 20, 50 AND 380 MG/DL¿ WITH THE SUBJECT METER ON UNSPECIFIED DATES/TIMES. THE PATIENT MANAGES HER DIABETES WITH A COMBINATION OF DIABETES MEDICATIONS (TRULICITY, WEEKLY INJECTION OF 6 UNITS; INSULIN TRESIBA, 34 UNITS ONCE PER DAY; INSULIN FIASP, FIXED DOSE 3 TO 5 TIMES PER DAY). IN RESPONSE TO THE ALLEGED INACCURATE READING OF ¿600 MG/DL¿, THE PATIENT REPORTED TAKING HER USUAL DOSE OF TRESIBA INSULIN THEN LATER THAT SAME DAY STARTED ¿FEELING OFF, WAS NOT ABLE TO MOVE OR TALK VERY WELL AND WAS FEELING LIKE GETTING A STROKE¿. THE PATIENT STATED HER DOCTOR VISITED HER AT HOME AND PERFORMED ANOTHER BLOOD GLUCOSE TEST WITH THE SUBJECT METER AND OBTAINED A RESULT OF ¿20 MG/DL¿. THE PATIENT STATED HER DOCTOR GAVE HER SOMETHING WITH SUGAR TO RAISE HER BLOOD

  Patient problems: Dysphasia; Hypoglycemia; Malaise; Paresis

  MAUDE report 17877280 ↗
• InjuryOct 5, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON SEPTEMBER 28, 2023, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT HER ONETOUCH VERIO IQ METER READ INACCURATELY COMPARED TO HER FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN A FEW WEEKS PRIOR TO CONTACTING LFS. THE PATIENT REPORTED OBTAINING ALLEGED INACCURATE READINGS OF ¿600, 20, 50 AND 380 MG/DL¿ WITH THE SUBJECT METER ON UNSPECIFIED DATES/TIMES. THE PATIENT MANAGES HER DIABETES WITH A COMBINATION OF DIABETES MEDICATIONS (TRULICITY, WEEKLY INJECTION OF 6 UNITS; INSULIN TRESIBA, 34 UNITS ONCE PER DAY; INSULIN FIASP, FIXED DOSE 3 TO 5 TIMES PER DAY). IN RESPONSE TO THE ALLEGED INACCURATE READING OF ¿600 MG/DL¿, THE PATIENT REPORTED TAKING HER USUAL DOSE OF TRESIBA INSULIN THEN LATER THAT SAME DAY STARTED ¿FEELING OFF, WAS NOT ABLE TO MOVE OR TALK VERY WELL AND WAS FEELING LIKE GETTING A STROKE¿. THE PATIENT STATED HER DOCTOR VISITED HER AT HOME AND PERFORMED ANOTHER BLOOD GLUCOSE TEST WITH THE SUBJECT METER AND OBTAINED A RESULT OF ¿20 MG/DL¿. THE PATIENT STATED HER DOCTOR GAVE HER SOMETHING WITH SUGAR TO RAISE HER BLOOD

  Patient problems: Dysphasia; Hypoglycemia; Malaise; Paresis

  MAUDE report 17877165 ↗
• InjuryMay 30, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2023, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS), ALLEGING THAT THEIR ONETOUCH VERIO IQ METER READ INACCURATELY HIGH COMPARED TO A LABORATORY METHOD. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION AND ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) AFTER REVIEWING THE CALL RECORDING. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN AT LUNCHTIME ON (B)(6) 2023 WHEN THEY OBTAINED AN UNSPECIFIED READING WITH THE SUBJECT METER. THE PATIENT MANAGES THEIR DIABETES WITH A SET DOSE OF INSULIN (HUMALOG, THREE TIMES A DAY BEFORE MEALS; HUMULIN, MORNING AND NIGHT). THE PATIENT DENIED MAKING ANY CHANGES TO THEIR USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED ISSUE. THE PATIENT CLAIMED THAT AROUND 4 HOURS AFTER THE ALLEGED ISSUE BEGAN, THEIR ¿SUGAR DROPPED¿ WHILE AT THE HOSPITAL FOR AN APPOINTMENT, AND THEY ¿PASSED OUT¿ AND GOT AN ¿ARM AND HEAD CONTUSION¿. AS A RESULT, THE PATIENT REPORTED THAT THEY WERE TREATED BY A NURSE WITH SUGAR AND JUICE THEN HOSPITALIZED FOR MORE TESTS. AFTER RECEIVING TREATMENT, THE PATIENT CLAIMED THEY RECEIVED A BLOOD GLUCOSE LAB RESULT OF ¿84 MG/DL¿ COMPARED TO T

  Patient problems: Bruise/Contusion; Syncope/Fainting

  MAUDE report 17027827 ↗
• InjuryMay 30, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2023, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS), ALLEGING THAT THEIR ONETOUCH VERIO IQ METER READ INACCURATELY HIGH COMPARED TO A LABORATORY METHOD. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION AND ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) AFTER REVIEWING THE CALL RECORDING. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN AT LUNCHTIME ON (B)(6) 2023 WHEN THEY OBTAINED AN UNSPECIFIED READING WITH THE SUBJECT METER. THE PATIENT MANAGES THEIR DIABETES WITH A SET DOSE OF INSULIN (HUMALOG, THREE TIMES A DAY BEFORE MEALS; HUMULIN, MORNING AND NIGHT). THE PATIENT DENIED MAKING ANY CHANGES TO THEIR USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED ISSUE. THE PATIENT CLAIMED THAT AROUND 4 HOURS AFTER THE ALLEGED ISSUE BEGAN, THEIR ¿SUGAR DROPPED¿ WHILE AT THE HOSPITAL FOR AN APPOINTMENT, AND THEY ¿PASSED OUT¿ AND GOT AN ¿ARM AND HEAD CONTUSION¿. AS A RESULT, THE PATIENT REPORTED THAT THEY WERE TREATED BY A NURSE WITH SUGAR AND JUICE THEN HOSPITALIZED FOR MORE TESTS. AFTER RECEIVING TREATMENT, THE PATIENT CLAIMED THEY RECEIVED A BLOOD GLUCOSE LAB RESULT OF ¿84 MG/DL¿ COMPARED TO T

  Patient problems: Bruise/Contusion; Syncope/Fainting

  MAUDE report 17027824 ↗
• InjuryDec 23, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2021, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT HIS ONETOUCH VERIO IQ METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE (EMERGENCY MEDICAL SERVICE METER). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY OCCURRED ON (B)(6) 2021. THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE READINGS OF ¿61 MG/DL¿ WITH THE SUBJECT METER AND ¿33 MG/DL¿ ON THE OTHER DEVICE, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. THE PATIENT STATED THAT HE MANAGES HIS DIABETES WITH INSULIN ON A SELF-ADJUSTING DOSE AND CLAIMED HE TOOK MORE FOOD/DRINK IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT STATED THAT HE FEELS WELL WITH A BLOOD GLUCOSE READING OF ¿61 MG/DL¿ HOWEVER HE ¿FAINTED¿ AFTER THE ALLEGED INACCURATE READING WAS OBTAINED AND EMERGENCY MEDICAL SERVICES (EMS) WERE CALLED FOR ASSISTANCE. WHEN EMS ARRIVED, THE PATIENT CLAIMED HIS BLOOD GLUCOSE MEASURED ¿33 MG/DL¿ ON THE EMS DEVICE. NO FURTHER TREATMENT WAS SPECIFIED. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CCA NOTED AN APPROVED SAMPLE SITE WAS USED FOR TESTI

  Patient problems: Hypoglycemia; Syncope/Fainting

  MAUDE report 13082577 ↗
• InjuryDec 23, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2021, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT HIS ONETOUCH VERIO IQ METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE (EMERGENCY MEDICAL SERVICE METER). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY OCCURRED ON (B)(6) 2021. THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE READINGS OF ¿61 MG/DL¿ WITH THE SUBJECT METER AND ¿33 MG/DL¿ ON THE OTHER DEVICE, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. THE PATIENT STATED THAT HE MANAGES HIS DIABETES WITH INSULIN ON A SELF-ADJUSTING DOSE AND CLAIMED HE TOOK MORE FOOD/DRINK IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT STATED THAT HE FEELS WELL WITH A BLOOD GLUCOSE READING OF ¿61 MG/DL¿ HOWEVER HE ¿FAINTED¿ AFTER THE ALLEGED INACCURATE READING WAS OBTAINED AND EMERGENCY MEDICAL SERVICES (EMS) WERE CALLED FOR ASSISTANCE. WHEN EMS ARRIVED, THE PATIENT CLAIMED HIS BLOOD GLUCOSE MEASURED ¿33 MG/DL¿ ON THE EMS DEVICE. NO FURTHER TREATMENT WAS SPECIFIED. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CCA NOTED AN APPROVED SAMPLE SITE WAS USED FOR TESTI

  Patient problems: Hypoglycemia; Syncope/Fainting

  MAUDE report 13082576 ↗
• InjuryDec 17, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON DECEMBER 2, 2021, THE PATIENT/LAY USER CONTACTED LIFESCAN (LFS) USA ALLEGING THAT HIS ONETOUCH VERIO IQ METER READ INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE BEGAN ON (B)(6) 2021, IN THE EVENING. THE PATIENT CLAIMED OBTAINING A BLOOD GLUCOSE READING OF ¿80 MG/DL¿ WITH THE SUBJECT METER AND INDICATED THAT AFTER THE READING HE ¿HAD A FAINT, COULD NOT MOVE¿ AND HAD TO CALL FOR HELP. WITHIN 30 MINUTES THE PARAMEDICS ARRIVED AND THEY OBTAINED A BLOOD GLUCOSE READING OF ¿43 MG/DL¿ ON AN EMERGENCY MEDICAL SERVICES (EMS) METER. THE PATIENT MANAGES HIS DIABETES WITH DIET AND EXERCISE AND CLAIMED THAT HE DID NOT MAKE ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT INFORMED THE CCA THAT HE WAS TREATED BY AN HCP WITH A GLUCOSE INJECTION. DURING TROUBLESHOOTING, THE CCA CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER, THE PATIENT HAD USED AN APPROVED SAMPLE SITE TO OBTAIN THE BLOOD SAMPLES AND THAT THE PATIENT WAS FOLLOWING THE CORRECT TESTING PROCEDURE. THE CCA NOTED

  Patient problems: Paresis; Presyncope

  MAUDE report 13031082 ↗
• InjuryDec 17, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2021, THE PATIENT/LAY USER CONTACTED LIFESCAN (LFS) USA ALLEGING THAT HIS ONETOUCH VERIO IQ METER READ INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE BEGAN ON (B)(6) 2021, IN THE EVENING. THE PATIENT CLAIMED OBTAINING A BLOOD GLUCOSE READING OF ¿80 MG/DL¿ WITH THE SUBJECT METER AND INDICATED THAT AFTER THE READING HE ¿HAD A FAINT, COULD NOT MOVE¿ AND HAD TO CALL FOR HELP. WITHIN 30 MINUTES THE PARAMEDICS ARRIVED AND THEY OBTAINED A BLOOD GLUCOSE READING OF ¿43 MG/DL¿ ON AN EMERGENCY MEDICAL SERVICES (EMS) METER. THE PATIENT MANAGES HIS DIABETES WITH DIET AND EXERCISE AND CLAIMED THAT HE DID NOT MAKE ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT INFORMED THE CCA THAT HE WAS TREATED BY AN HCP WITH A GLUCOSE INJECTION. DURING TROUBLESHOOTING, THE CCA CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER, THE PATIENT HAD USED AN APPROVED SAMPLE SITE TO OBTAIN THE BLOOD SAMPLES AND THAT THE PATIENT WAS FOLLOWING THE CORRECT TESTING PROCEDURE. THE CCA NOTED THAT

  Patient problems: Paresis; Presyncope

  MAUDE report 13031081 ↗
• InjuryOct 14, 2021Device Displays Incorrect Message; Device Displays Incorrect Message

  ON (B)(6) 2021, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT THEIR ONETOUCH VERIO IQ METER WAS DISPLAYING AN ERROR 1 MESSAGE DURING TESTING. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ERROR MESSAGE BEGAN TO APPEAR ON THE EVENING OF (B)(6) 2021. IT WAS NOT REPORTED WHAT MEDICATION, IF ANY, THE PATIENT TAKES TO MANAGE THEIR DIABETES. THE PATIENT CLAIMED THEY WERE NOT ABLE TO ADJUST THEIR DIET WELL AS THEY WAS UNABLE TO TEST THEIR BLOOD GLUCOSE DUE TO THE ERROR MESSAGE APPEARING. ON (B)(6) 2021, AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT CLAIMED THEY DEVELOPED SYMPTOM OF TREMOR; SYMPTOM THEY ASSOCIATED WITH HYPOGLYCEMIA. THE PATIENT CLAIMED THEY SELF-TREATED WITH FOOD AND THE SYMPTOM RESOLVED. THE PATIENT DENIED USING ANY OTHER DEVICE TO TEST THEIR BLOOD GLUCOSE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME. THE CCA WALKED THE PATIENT THROUGH RESOLVING THE ISSUE HOWEVER THE ALLEGED ISSUE WAS NOT RESOLVED. REPLACEMENT PRODUCT WAS PROVIDED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED THEY WE

  Patient problems: Hypoglycemia; Shaking/Tremors

  MAUDE report 12630192 ↗
• InjuryOct 14, 2021Device Displays Incorrect Message; Device Displays Incorrect Message

  ON SEPTEMBER 24, 2021, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(6), ALLEGING THAT THEIR ONETOUCH VERIO IQ METER WAS DISPLAYING AN ¿ERROR 1¿ MESSAGE DURING TESTING. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ERROR MESSAGE BEGAN TO APPEAR ON THE EVENING OF (B)(6) 2021. IT WAS NOT REPORTED WHAT MEDICATION, IF ANY, THE PATIENT TAKES TO MANAGE THEIR DIABETES. THE PATIENT CLAIMED THEY WERE NOT ABLE TO ADJUST THEIR DIET WELL AS THEY WAS UNABLE TO TEST THEIR BLOOD GLUCOSE DUE TO THE ERROR MESSAGE APPEARING. ON (B)(6) 2021, AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT CLAIMED THEY DEVELOPED SYMPTOM OF ¿TREMOR;¿ SYMPTOM THEY ASSOCIATED WITH HYPOGLYCEMIA. THE PATIENT CLAIMED THEY SELF-TREATED WITH FOOD AND THE SYMPTOM RESOLVED. THE PATIENT DENIED USING ANY OTHER DEVICE TO TEST THEIR BLOOD GLUCOSE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME. THE CCA WALKED THE PATIENT THROUGH RESOLVING THE ISSUE HOWEVER THE ALLEGED ISSUE WAS NOT RESOLVED. REPLACEMENT PRODUCT WAS PROVIDED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED

  Patient problems: Hypoglycemia; Shaking/Tremors

  MAUDE report 12630131 ↗
• InjurySep 13, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2021, THE LAY-USER/ PATIENT¿S SON (THE REPORTER) CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO IQ METER READ INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA) DURING A FOLLOW-UP CALL WITH THE REPORTER. THE CCA WAS ADVISED BY THE REPORTER THAT ON (B)(6) 2021 AT 11:30 PM, THE PATIENT OBTAINED AN ALLEGED INACCURATE HIGH BLOOD GLUCOSE READING OF BETWEEN ¿190 TO 220 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT MANAGES HIS DIABETES WITH HUMULIN 70/30 INSULIN ON A SELF-ADJUSTING DOSE. THE REPORTER CLAIMED THAT IN RESPONSE TO THE ALLEGED ISSUE, THE PATIENT TOOK AN UNSPECIFIED DOSE OF INSULIN TO LOWER HIS BLOOD GLUCOSE THEN PATIENT ¿FAINTED.¿ DURING THE FOLLOW-UP CALL, THE REPORTER CLAIMED THE PATIENT WAS UNCONSCIOUS FOR BETWEEN 10-15 MINUTES. THE REPORTER CLAIMED THE PATIENT WAS TREATED BY EMERGENCY MEDICAL SERVICES (EMS) WITH ¿SERUM¿ AND WITH ¿LIQUID¿ THAT THEY ADMINISTERED SLOWLY; EXACT DETAILS WERE UNABLE TO BE PROVIDED. THE REPORTER STATED THAT THE PATIENT¿S BLOOD GLUCOSE WAS MEASURED WITH THE EMS METER UNTIL HE STABILIZED

  Patient problems: Syncope/Fainting

  MAUDE report 12465429 ↗
• InjurySep 13, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2021, THE LAY-USER/PATIENT¿S SON (THE REPORTER) CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO IQ METER READ INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA) DURING A FOLLOW-UP CALL WITH THE REPORTER. THE CCA WAS ADVISED BY THE REPORTER THAT ON (B)(6) 2021 AT 11:30 PM, THE PATIENT OBTAINED AN ALLEGED INACCURATE HIGH BLOOD GLUCOSE READING OF BETWEEN ¿190 TO 220 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT MANAGES HIS DIABETES WITH HUMULIN 70/30 INSULIN ON A SELF-ADJUSTING DOSE. THE REPORTER CLAIMED THAT IN RESPONSE TO THE ALLEGED ISSUE, THE PATIENT TOOK AN UNSPECIFIED DOSE OF INSULIN TO LOWER HIS BLOOD GLUCOSE THEN PATIENT ¿FAINTED.¿ DURING THE FOLLOW-UP CALL, THE REPORTER CLAIMED THE PATIENT WAS UNCONSCIOUS FOR BETWEEN 10-15 MINUTES. THE REPORTER CLAIMED THE PATIENT WAS TREATED BY EMERGENCY MEDICAL SERVICES (EMS) WITH ¿SERUM¿ AND WITH ¿LIQUID¿ THAT THEY ADMINISTERED SLOWLY; EXACT DETAILS WERE UNABLE TO BE PROVIDED. THE REPORTER STATED THAT THE PATIENT¿S BLOOD GLUCOSE WAS MEASURED WITH THE EMS METER UNTIL HE STABILIZED H

  Patient problems: Syncope/Fainting

  MAUDE report 12465427 ↗
• InjuryAug 23, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2021, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT HIS ONETOUCH VERIO IQ METER READ INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN ON THE EVENING OF (B)(6) 2021. THE PATIENT REPORTED OBTAINING ALLEGED INACCURATE HIGH BLOOD GLUCOSE READINGS OF ¿170 AND 290 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT STATED THAT HE MANAGES HIS DIABETES WITH LONG- AND SHORT-ACTING INSULIN (SELF-ADJUSTER) AND TOOK 5-6 UNITS OF INSULIN (TYPE NOT REPORTED) IN RESPONSE TO THE ¿290 MG/DL¿ READING. ON THE EVENING OF (B)(6) 2021, AFTER THE INSULIN WAS ADMINISTERED, THE PATIENT CLAIMED HE BEGAN TO FEEL SYMPTOM OF ¿BODY SHAKING¿ AND OBTAINED A READING OF ¿65 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT WAS UNWILLING TO SPECIFY THE TREATMENT RECEIVED. NO OTHER DEVICE WAS USED FOR TESTING. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CCA NOTED THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO PERFORM A QUALITY CONTROL TEST. REPLACEMENT PRODUC

  Patient problems: Shaking/Tremors

  MAUDE report 12356958 ↗
• InjuryAug 23, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2021, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT HIS ONETOUCH VERIO IQ METER READ INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN ON THE EVENING OF (B)(6) 2021. THE PATIENT REPORTED OBTAINING ALLEGED INACCURATE HIGH BLOOD GLUCOSE READINGS OF ¿170 AND 290 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT STATED THAT HE MANAGES HIS DIABETES WITH LONG- AND SHORT-ACTING INSULIN (SELF-ADJUSTER) AND TOOK 5-6 UNITS OF INSULIN (TYPE NOT REPORTED) IN RESPONSE TO THE ¿290 MG/DL¿ READING. ON THE EVENING OF (B)(6) 2021, AFTER THE INSULIN WAS ADMINISTERED, THE PATIENT CLAIMED HE BEGAN TO FEEL SYMPTOM OF ¿BODY SHAKING¿ AND OBTAINED A READING OF ¿65 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT WAS UNWILLING TO SPECIFY THE TREATMENT RECEIVED. NO OTHER DEVICE WAS USED FOR TESTING. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CCA NOTED THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO PERFORM A QUALITY CONTROL TEST. REPLACEMENT PRODUC

  Patient problems: Hypoglycemia; Shaking/Tremors

  MAUDE report 12356957 ↗
• InjuryJun 23, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2021, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HIS ONETOUCH VERIO IQ METER WAS READING INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL AND ADDITIONAL INFORMATION AFTER CCA REVIEWED THE CALL. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY ISSUE BEGAN AT 6:05PM ON (B)(6) 2021. THE PATIENT CLAIMED OBTAINING A BLOOD GLUCOSE READING OF ¿138 MG/DL¿ WITH THE SUBJECT DEVICE WHICH HE FELT WAS INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. THE PATIENT MANAGES HIS DIABETES WITH ORAL MEDICATIONS AND INSULIN AND STATED THAT HE TOOK 5MG OF INSULIN IN RESPONSE TO THE ALLEGED PRODUCT ISSUE. THE PATIENT REPORTED THAT AT 6:35PM ON (B)(6) 2021, HE DEVELOPED SYMPTOMS ¿SHAKINESS¿ AS A RESULT OF THE ALLEGED PRODUCT ISSUE. HE REPORTED THAT HE SELF-TREATED BY CONSUMING SOME FOOD ¿ATE CANDY¿. THE PATIENT DENIED THAT HE OBTAINED A BLOOD GLUCOSE RESULT ON ANOTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT DEVICE AT THE TIME OF TESTING, THE CCA AL

  Patient problems: Shaking/Tremors

  MAUDE report 12054644 ↗
• InjuryJun 23, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2021, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HIS ONETOUCH VERIO IQ METER WAS READING INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL AND ADDITIONAL INFORMATION AFTER CCA REVIEWED THE CALL. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY ISSUE BEGAN AT 6:05PM ON (B)(6) 2021. THE PATIENT CLAIMED OBTAINING A BLOOD GLUCOSE READING OF ¿138 MG/DL¿ WITH THE SUBJECT DEVICE WHICH HE FELT WAS INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. THE PATIENT MANAGES HIS DIABETES WITH ORAL MEDICATIONS AND INSULIN AND STATED THAT HE TOOK 5MG OF INSULIN IN RESPONSE TO THE ALLEGED PRODUCT ISSUE. THE PATIENT REPORTED THAT AT 6:35PM ON (B)(6) 2021, HE DEVELOPED SYMPTOMS ¿SHAKINESS¿ AS A RESULT OF THE ALLEGED PRODUCT ISSUE. HE REPORTED THAT HE SELF-TREATED BY CONSUMING SOME FOOD ¿ATE CANDY¿. THE PATIENT DENIED THAT HE OBTAINED A BLOOD GLUCOSE RESULT ON ANOTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT DEVICE AT THE TIME OF TESTING, THE CCA AL

  Patient problems: Shaking/Tremors

  MAUDE report 12054643 ↗
• InjuryJun 22, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2021, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING HIS ONETOUCH VERIO IQ METER READ INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL RESULTS. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL AND SUPPLEMENTARY INFORMATION OBTAINED WHEN THE CALL RECORDING WAS REVIEWED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS). THE CCA ATTEMPTED TO FOLLOW UP AT MS REQUEST, HOWEVER, WAS UNABLE TO REACH THE PATIENT BY PHONE. THE PATIENT DID NOT SPECIFY WHEN THE ALLEGED ISSUE STARTED, HOWEVER STATED THAT HE SOMETIMES RECEIVES BLOOD GLUCOSE READINGS OF ¿300 OR 400 MG/DL¿. THE PATIENT THEN RETESTS, AND THE SECOND READING IS USUALLY CLOSER TO HOW HE FEELS. DURING THE CALL, THE PATIENT MENTIONS THAT AT AN UNSPECIFIED DATE AND TIME HE RECEIVED A BLOOD GLUCOSE READING OF ¿269 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT INFORMED THE CCA THAT HE USUALLY MANAGES HIS DIABETES WITH INSULIN (TWICE A DAY ¿ TYPE UNSPECIFIED) AND CLAIMED ON THE CALL THAT HE ADMINISTERED A HIGHER DOSE OF FAST ACTING INSULIN THAN USUAL BASED ON THE METER READING. AT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE THE PATIENT DEVELOPED SYM

  Patient problems: Hypoglycemia

  MAUDE report 12046780 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110637. One submission often covers many models, so check the product and lot details in each record.

• Z-1359-2012 · Feb 21, 2012 · Terminated
  OneTouch Verio IQ Blood Glucose Monitoring System Kit; One Touch Verio IQ Blood Glucose IQ Blood Glucose Monitoring Starter Kit; One Touch Verio IQ Blood Glucose Monitoring Warrant