OneTouch Verio IQRecalls & reported problems across all models
LifeScan Europe GmbH · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6,147
- Deaths reported
- 0
- Injuries reported
- 329
- Recalls
- 0
We found 3 models of OneTouch Verio IQ by LifeScan Europe GmbH in the FDA's device registry (GUDID). Together they are named in 6,147 adverse event reports in the FDA's MAUDE database, received between Nov 18, 2016 and Jul 23, 2024 — classified as 329 injuries, 5,815 malfunctions.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (2,945 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported OneTouch Verio IQ problems
Device problems
- Device Displays Incorrect Message2,945
- Incorrect Or Inadequate Test Results901
- Incorrect, Inadequate or Imprecise Result or Readings408
- Loss of Power289
- Low Battery286
- Device Alarm System282
- Battery Problem277
- Component Missing202
Patient problems
- No Consequences Or Impact To Patient5,811
- Shaking/Tremors134
- Sweating87
- Dizziness81
- Blurred Vision29
- Hypoglycemia27
- Confusion/ Disorientation25
- Fatigue22
OneTouch Verio IQ models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OneTouch Verio IQ 022-275Glucose dehydrogenase, glucose6,035 reports
- OneTouch Verio IQ 022-268Glucose dehydrogenase, glucose76 reports
- OneTouch Verio IQ 022-267SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER36 reports
Recent OneTouch Verio IQ adverse event reports
The 15 most recent reports across all models, 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 ↗
Other LifeScan Europe GmbH products
All LifeScan Europe GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page