OneTouch Verio 022-659Recalls & reported problems

Summary

The FDA's MAUDE database contains 4,219 adverse event reports that list this exact device (DI 00353885008730), received between Nov 22, 2016 and Oct 16, 2024 — classified as 325 injuries, 3,893 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (2,070 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, 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 4,219 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2024Device Handling Problem; Device Handling Problem

  ON SEPTEMBER 23, 2024, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT HIS ONETOUCH VERIO2 METER READ INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. 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. THE PATIENT REPORTED THAT ON (B)(6) 2024, AT 1:00 AM, HE OBTAINED AN INACCURATE HIGH BLOOD GLUCOSE READING OF ¿70 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT MENTIONED THAT HE MANAGES HIS DIABETES WITH HUMALOG INSULIN (6 UNITS BEFORE EACH MEAL ON A SLIDING SCALE) AND TRESIBA INSULIN (TWICE A DAY). HE REPORTED THAT SHORTLY AFTER THE ALLEGED ISSUE OCCURRED, HE DEVELOPED SYMPTOMS OF ¿SWEATY AND HEADACHE¿. HIS MOTHER PHONED HIM, AND SHE CALLED THE EMERGENCY MEDICAL SERVICES (EMS) FOR ASSISTANCE. WHILE WAITING FOR EMS TO ARRIVE, HE CLAIMED HE DRANK ORANGE JUICE AND WENT TO SLEEP. DURING THE CALL, THE PATIENT STATED THAT WHEN EMS ARRIVED AT HIS HOME, THEY ALMOST BROKE HIS DOOR DOWN BECAUSE THEY ¿COULDN¿T WAKE HIM UP.¿ HE MENTIONED THAT IT TOOK THEM 10 MINUTES TO WAKE HIM UP TO ANSWER THE DOOR AND AT AROU

  Patient problems: Diaphoresis; Headache; Hypoglycemia; Sleepiness/Drowsiness/Somnolence

  MAUDE report 20459038 ↗
• InjuryOct 15, 2024Device Handling Problem; Device Handling Problem

  ON (B)(6) 2024, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT HIS ONETOUCH VERIO2 METER READ INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. 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. THE PATIENT REPORTED THAT ON (B)(6) 2024, AT 1:00 AM, HE OBTAINED AN INACCURATE HIGH BLOOD GLUCOSE READING OF ¿70 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT MENTIONED THAT HE MANAGES HIS DIABETES WITH HUMALOG INSULIN (6 UNITS BEFORE EACH MEAL ON A SLIDING SCALE) AND TRESIBA INSULIN (TWICE A DAY). HE REPORTED THAT SHORTLY AFTER THE ALLEGED ISSUE OCCURRED, HE DEVELOPED SYMPTOMS OF ¿SWEATY AND HEADACHE¿. HIS MOTHER PHONED HIM, AND SHE CALLED THE EMERGENCY MEDICAL SERVICES (EMS) FOR ASSISTANCE. WHILE WAITING FOR EMS TO ARRIVE, HE CLAIMED HE DRANK ORANGE JUICE AND WENT TO SLEEP. DURING THE CALL, THE PATIENT STATED THAT WHEN EMS ARRIVED AT HIS HOME, THEY ALMOST BROKE HIS DOOR DOWN BECAUSE THEY ¿COULDN¿T WAKE HIM UP.¿ HE MENTIONED THAT IT TOOK THEM 10 MINUTES TO WAKE HIM UP TO ANSWER THE DOOR AND AT AROUND 1:40

  Patient problems: Diaphoresis; Headache; Hypoglycemia; Sleepiness/Drowsiness/Somnolence

  MAUDE report 20457787 ↗
• InjuryDec 18, 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) UNITED STATES, ALLEGING THAT HER ONETOUCH VERIO2 METER READ INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION AND ON ADDITIONAL INFORMATION OBTAINED WHEN THE MEDICAL SURVEILLANCE SPECIALIST REVIEWED THE CALL RECORDING. DURING THE CALL, THE PATIENT WAS UNABLE TO CONFIRM WHEN THE ALLEGED METER INACCURACY BEGAN. THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH ORAL MEDICATION (METFORMIN 500 MG ONCE DAILY). SHE DID NOT REPORT MAKING ANY CHANGES TO HER NORMAL DIABETES MANAGEMENT REGIMEN DUE TO THE ALLEGED ISSUE. ON (B)(6), 2023, AT 11:38 AM, THE PATIENT CLAIMED SHE WOKE UP WITH HYPOGLYCEMIC SYMPTOMS DESCRIBED AS ¿SWEATY, WEAK AND FELT LIKE PASSING OUT.¿ IN RESPONSE TO THE SYMPTOMS, THE PATIENT STATED THAT SHE TESTED HER BLOOD GLUCOSE WITH THE SUBJECT METER AND OBTAINED BACK-TO-BACK RESULTS OF ¿545, 229, 217 MG/DL.¿. THE TESTS WERE TAKEN WITHIN 3 MINUTES OF EACH OTHER. THE PATIENT STATED THAT SHE SAT FOR A WHILE AND TREATED HERSELF WITH FOOD (PEANUT BUTTER AND CRACKERS) AT 11:45 AM, SHORTLY AFTER TAKING THE TESTS. THE PATIENT DID NOT USE ANY OTHER DEVICE TO TEST HER B

  Patient problems: Diaphoresis; Fatigue; Hypoglycemia; Presyncope

  MAUDE report 18343347 ↗
• InjuryDec 18, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON DECEMBER 5, 2023, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT HER ONETOUCH VERIO2 METER READ INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION AND ON ADDITIONAL INFORMATION OBTAINED WHEN THE MEDICAL SURVEILLANCE SPECIALIST REVIEWED THE CALL RECORDING. DURING THE CALL, THE PATIENT WAS UNABLE TO CONFIRM WHEN THE ALLEGED METER INACCURACY BEGAN. THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH ORAL MEDICATION (METFORMIN 500 MG ONCE DAILY). SHE DID NOT REPORT MAKING ANY CHANGES TO HER NORMAL DIABETES MANAGEMENT REGIMEN DUE TO THE ALLEGED ISSUE. ON (B)(6), 2023, AT 11:38 AM, THE PATIENT CLAIMED SHE WOKE UP WITH HYPOGLYCEMIC SYMPTOMS DESCRIBED AS ¿SWEATY, WEAK AND FELT LIKE PASSING OUT.¿ IN RESPONSE TO THE SYMPTOMS, THE PATIENT STATED THAT SHE TESTED HER BLOOD GLUCOSE WITH THE SUBJECT METER AND OBTAINED BACK-TO-BACK RESULTS OF ¿545, 229, 217 MG/DL.¿. THE TESTS WERE TAKEN WITHIN 3 MINUTES OF EACH OTHER. THE PATIENT STATED THAT SHE SAT FOR A WHILE AND TREATED HERSELF WITH FOOD (PEANUT BUTTER AND CRACKERS) AT 11:45 AM, SHORTLY AFTER TAKING THE TESTS. THE PATIENT DID NOT USE ANY OTHER DEVICE TO TEST H

  Patient problems: Diaphoresis; Fatigue; Hypoglycemia; Presyncope

  MAUDE report 18343346 ↗
• InjuryDec 12, 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) USA, ALLEGING THAT HER ONETOUCH VERIO 2 METER DISPLAYED INACCURATELY ERRATIC BLOOD GLUCOSE RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION OF THE INITIAL CALL. THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6), 2023, AT 7:56 PM. THE PATIENT OBTAINED BLOOD GLUCOSE READINGS OF ¿387, 68, 349, 323, 88, 95 AND 72 MG/DL¿ ON THE SUBJECT METER, WITHIN 20 MINUTES OF EACH OTHER. THE PATIENT MANAGES HER DIABETES WITH UNSPECIFIED INSULIN, DOSAGE BASED ON THE METER READINGS. THE PATIENT STATED THAT SHE TOOK HER USUAL DOSE OF INSULIN IN RESPONSE TO THE ALLEGED ISSUE. IMMEDIATELY AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT DEVELOPED SYMPTOMS OF ¿DIZZY, SHAKING, HEADACHE, SWEATING AND CONFUSION¿. THE PATIENT DENIED RECEIVING ANY TREATMENT FOR THE REPORTED SYMPTOMS. DURING TROUBLESHOOTING, THE CCA ESTABLISHED THAT THE TEST STRIPS HAD NOT BEEN OPEN LONGER THAN THE DISCARD DATE, HAD NOT EXPIRED, AND HAD BEEN STORED CORRECTLY. THE REPORTER CONFIRMED THAT THE PATIENT HAD USED AN APPROVED SAMPLE SITE TO OBTAIN THE BLOOD SAMPLE AND THAT THE PATIENT HAD USED A CORRECT TESTING METHOD. THE PATIENT DI

  Patient problems: Confusion/ Disorientation; Diaphoresis; Dizziness; Headache; Shaking/Tremors

  MAUDE report 18308717 ↗
• InjuryDec 12, 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) USA, ALLEGING THAT HER ONETOUCH VERIO 2 METER DISPLAYED INACCURATELY ERRATIC BLOOD GLUCOSE RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION OF THE INITIAL CALL. THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6), 2023, AT 7:56 PM. THE PATIENT OBTAINED BLOOD GLUCOSE READINGS OF ¿387, 68, 349, 323, 88, 95 AND 72 MG/DL¿ ON THE SUBJECT METER, WITHIN 20 MINUTES OF EACH OTHER. THE PATIENT MANAGES HER DIABETES WITH UNSPECIFIED INSULIN, DOSAGE BASED ON THE METER READINGS. THE PATIENT STATED THAT SHE TOOK HER USUAL DOSE OF INSULIN IN RESPONSE TO THE ALLEGED ISSUE. IMMEDIATELY AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT DEVELOPED SYMPTOMS OF ¿DIZZY, SHAKING, HEADACHE, SWEATING AND CONFUSION¿. THE PATIENT DENIED RECEIVING ANY TREATMENT FOR THE REPORTED SYMPTOMS. DURING TROUBLESHOOTING, THE CCA ESTABLISHED THAT THE TEST STRIPS HAD NOT BEEN OPEN LONGER THAN THE DISCARD DATE, HAD NOT EXPIRED, AND HAD BEEN STORED CORRECTLY. THE REPORTER CONFIRMED THAT THE PATIENT HAD USED AN APPROVED SAMPLE SITE TO OBTAIN THE BLOOD SAMPLE AND THAT THE PATIENT HAD USED A CORRECT TESTING METHOD. THE PATIENT DI

  Patient problems: Confusion/ Disorientation; Diaphoresis; Dizziness; Headache; Shaking/Tremors

  MAUDE report 18308700 ↗
• InjuryAug 28, 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) UNITED STATES, ALLEGING THAT HIS ONETOUCH VERIO2 METER READ INACCURATELY HIGH COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST AFTER REVIEWING THE CALL RECORDING, SINCE ATTEMPTS TO REACH THE PATIENT BY PHONE TO OBTAIN FURTHER INFORMATION WERE UNSUCCESSFUL. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY OCCURRED BETWEEN (B)(6), 2023, AND (B)(6), 2023. THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE READINGS OF ¿598 MG/DL¿ WITH THE SUBJECT METER AND ¿500 MG/DL¿ ON THE OTHER METER (VERIO FLEX), PERFORMED WITHIN 30 MINUTES OF EACH OTHER. THE PATIENT MANAGES HIS DIABETES WITH A COMBINATION OF INSULIN (BASAGLAR; HUMALOG - SLIDING SCALE BASED ON BLOOD GLUCOSE READINGS) AND STATED HE TESTS HIS BLOOD GLUCOSE 10-15 TIMES A DAY. IN RESPONSE TO THE ALLEGED INACCURATE READING(S), THE PATIENT CLAIMED HE TOOK AN INCREASED DOSE OF 25 UNITS OF HUMALOG, FOLLOWED BY MORE INSULIN WHEN HE CONTINUED TO RECEIVE HIGH READINGS, AND TOOK A TOTAL OF AROUND 40-45 UNITS OF HUMALOG ON THE EVENING OF (B)(6), 2023. AS A RESULT, THE PATIENT REPORTED EXPERIENCING

  Patient problems: Convulsion/Seizure; Dizziness; Hypoglycemia; Syncope/Fainting

  MAUDE report 17638665 ↗
• InjuryAug 28, 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) UNITED STATES, ALLEGING THAT HIS ONETOUCH VERIO2 METER READ INACCURATELY HIGH COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST AFTER REVIEWING THE CALL RECORDING, SINCE ATTEMPTS TO REACH THE PATIENT BY PHONE TO OBTAIN FURTHER INFORMATION WERE UNSUCCESSFUL. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY OCCURRED BETWEEN (B)(6), 2023. THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE READINGS OF ¿598 MG/DL¿ WITH THE SUBJECT METER AND ¿500 MG/DL¿ ON THE OTHER METER (VERIO FLEX), PERFORMED WITHIN 30 MINUTES OF EACH OTHER. THE PATIENT MANAGES HIS DIABETES WITH A COMBINATION OF INSULIN (BASAGLAR; HUMALOG - SLIDING SCALE BASED ON BLOOD GLUCOSE READINGS) AND STATED HE TESTS HIS BLOOD GLUCOSE 10-15 TIMES A DAY. IN RESPONSE TO THE ALLEGED INACCURATE READING(S), THE PATIENT CLAIMED HE TOOK AN INCREASED DOSE OF 25 UNITS OF HUMALOG, FOLLOWED BY MORE INSULIN WHEN HE CONTINUED TO RECEIVE HIGH READINGS, AND TOOK A TOTAL OF AROUND 40-45 UNITS OF HUMALOG ON THE EVENING OF (B)(6) 2023. AS A RESULT, THE PATIENT REPORTED EXPERIENCING 4 "HYPOGLYCEMIC ATT

  Patient problems: Convulsion/Seizure; Dizziness; Hypoglycemia; Syncope/Fainting

  MAUDE report 17638663 ↗
• InjuryAug 7, 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 HER ONETOUCH VERIO2 METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. IT WAS NOT REPORTED WHEN THE ALLEGED METER INACCURACY BEGAN. THE PATIENT REPORTED OBTAINING HIGH READINGS WHILE SHE WAS EXPERIENCING LOW BLOOD GLUCOSE SYMPTOMS. THE PATIENT CLAIMED THAT ON ONE OCCASION, ON THE MORNING OF (B)(6) 2023, SHE EXPERIENCED SYMPTOMS OF ¿SHAKING AND SWEATING¿ AND RECEIVED A READING OF ¿15.0 MMOL/L¿ WITH THE SUBJECT METER. DESPITE THE ALLEGED ELEVATED RESULT, THE PATIENT CLAIMED SHE TREATED HERSELF WITH ORANGE JUICE AND FELT BETTER AFTERWARDS. THE PATIENT MANAGES HER DIABETES WITH A COMBINATION OF ORAL MEDICATION (DIAMICRON) AND INSULIN (15 UNITS ONCE DAILY BEFORE BED). IT WAS NOT REPORTED IF THE PATIENT MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CCA CONFIRMED THE TEST STRIP VIAL WAS INTACT AND THE TEST STRIPS HAD BEEN STORED CORRECTLY AND WERE NOT EXPIRED OR OPENED P

  Patient problems: Diaphoresis; Shaking/Tremors

  MAUDE report 17477197 ↗
• InjuryAug 7, 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 HER ONETOUCH VERIO2 METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. IT WAS NOT REPORTED WHEN THE ALLEGED METER INACCURACY BEGAN. THE PATIENT REPORTED OBTAINING HIGH READINGS WHILE SHE WAS EXPERIENCING LOW BLOOD GLUCOSE SYMPTOMS. THE PATIENT CLAIMED THAT ON ONE OCCASION, ON THE MORNING OF (B)(6) 2023, SHE EXPERIENCED SYMPTOMS OF ¿SHAKING AND SWEATING¿ AND RECEIVED A READING OF ¿15.0 MMOL/L¿ WITH THE SUBJECT METER. DESPITE THE ALLEGED ELEVATED RESULT, THE PATIENT CLAIMED SHE TREATED HERSELF WITH ORANGE JUICE AND FELT BETTER AFTERWARDS. THE PATIENT MANAGES HER DIABETES WITH A COMBINATION OF ORAL MEDICATION (DIAMICRON) AND INSULIN (15 UNITS ONCE DAILY BEFORE BED). IT WAS NOT REPORTED IF THE PATIENT MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CCA CONFIRMED THE TEST STRIP VIAL WAS INTACT AND THE TEST STRIPS HAD BEEN STORED CORRECTLY AND WERE NOT EXPIRED OR OPENED P

  Patient problems: Diaphoresis; Shaking/Tremors

  MAUDE report 17476889 ↗
• InjuryJun 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON JUNE 6, 2023, THE LAY USER/PATIENT¿S SPOUSE CONTACTED LIFESCAN (LFS) CANADA, ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO2 METER READ INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL, SINCE THE REPORTER DECLINED TO PROVIDE ANY FURTHER INFORMATION. THE REPORTER STATED THAT THE ALLEGED METER INACCURACY BEGAN ON (B)(6) 2023, AT 12:30 PM. THE REPORTER CLAIMED THE PATIENT OBTAINED BLOOD GLUCOSE READINGS OF ¿6.1 AND 7.3 MMOL/L¿ WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. THE PATIENT MANAGES HIS DIABETES WITH ORAL MEDICATION (JANUVIA). AS A RESULT OF THE ALLEGED ISSUE, THE REPORTER CLAIMED THE PATIENT TOOK HIS USUAL DOSE OF MEDICATION AND DEVELOPED SYMPTOMS DESCRIBED AS ¿SHAKING BECAUSE HE WAS SCARED, NOT WELL AND STRESSED¿. THE REPORTER INDICATED THAT IT WAS HOT OUTSIDE AT THE TIME OF THE EVENT. THE REPORTER DECLINED TO PROVIDE ANY FURTHER INFORMATION REGARDING THE EVENT. DURING TROUBLESHOOTING, THE CCA CONFIRMED THE TEST STRIP VIAL WAS INTACT AND THE TEST STRIPS HAD BEEN STORED CORRECTLY AND WERE NOT EXPIRED OR OPENED PAST THEIR DISCARD DATE. THE CCA NOTED THE PATIENT DID N

  Patient problems: Anxiety; Malaise; Shaking/Tremors

  MAUDE report 17114307 ↗
• InjuryJun 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON JUNE 6, 2023, THE LAY USER/PATIENT¿S SPOUSE CONTACTED LIFESCAN (LFS) CANADA, ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO2 METER READ INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL, SINCE THE REPORTER DECLINED TO PROVIDE ANY FURTHER INFORMATION. THE REPORTER STATED THAT THE ALLEGED METER INACCURACY BEGAN ON (B)(6) 2023, AT 12:30 PM. THE REPORTER CLAIMED THE PATIENT OBTAINED BLOOD GLUCOSE READINGS OF ¿6.1 AND 7.3 MMOL/L¿ WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. THE PATIENT MANAGES HIS DIABETES WITH ORAL MEDICATION (JANUVIA). AS A RESULT OF THE ALLEGED ISSUE, THE REPORTER CLAIMED THE PATIENT TOOK HIS USUAL DOSE OF MEDICATION AND DEVELOPED SYMPTOMS DESCRIBED AS ¿SHAKING BECAUSE HE WAS SCARED, NOT WELL AND STRESSED¿. THE REPORTER INDICATED THAT IT WAS HOT OUTSIDE AT THE TIME OF THE EVENT. THE REPORTER DECLINED TO PROVIDE ANY FURTHER INFORMATION REGARDING THE EVENT. DURING TROUBLESHOOTING, THE CCA CONFIRMED THE TEST STRIP VIAL WAS INTACT AND THE TEST STRIPS HAD BEEN STORED CORRECTLY AND WERE NOT EXPIRED OR OPENED PAST THEIR DISCARD DATE. THE CCA NOTED THE PATIENT DID N

  Patient problems: Anxiety; Malaise; Shaking/Tremors

  MAUDE report 17114305 ↗
• InjurySep 16, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2022, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THEIR ONETOUCH VERIO2 METER READ INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION AND ON FURTHER INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST AFTER REVIEWING THE CALL RECORDING. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN 3 WEEKS PRIOR TO CONTACTING LFS. THE PATIENT REPORTED OBTAINING WHAT THEY FELT WERE INACCURATE HIGH BLOOD GLUCOSE READINGS OF ¿145, 120, 80, 109, 108, 110, 134 AND 147 MG/DL¿ WITH THE SUBJECT METER ON UNSPECIFIED DATES/TIMES. THE PATIENT MANAGES THEIR DIABETES WITH ORAL MEDICATION (METFORMIN) AND THEY CONTINUED TO FOLLOW THEIR USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT REPORTED THAT ON (B)(6) 2022, AT 5:30 PM, THEY EXPERIENCED A ¿LOW SUGAR¿ WITH SYMPTOMS OF ¿SWEATING AND SHAKING¿. THE PATIENT CLAIMED THEY SELF-TREATED WITH ORANGE JUICE. 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 CONFIRMED THE TES

  Patient problems: Diaphoresis; Hypoglycemia; Shaking/Tremors

  MAUDE report 15442745 ↗
• InjurySep 16, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2022, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THEIR ONETOUCH VERIO2 METER READ INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION AND ON FURTHER INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST AFTER REVIEWING THE CALL RECORDING. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN 3 WEEKS PRIOR TO CONTACTING LFS. THE PATIENT REPORTED OBTAINING WHAT THEY FELT WERE INACCURATE HIGH BLOOD GLUCOSE READINGS OF ¿145, 120, 80, 109, 108, 110, 134 AND 147 MG/DL¿ WITH THE SUBJECT METER ON UNSPECIFIED DATES/TIMES. THE PATIENT MANAGES THEIR DIABETES WITH ORAL MEDICATION (METFORMIN) AND THEY CONTINUED TO FOLLOW THEIR USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT REPORTED THAT ON (B)(6) 2022, AT 5:30 PM, THEY EXPERIENCED A ¿LOW SUGAR¿ WITH SYMPTOMS OF ¿SWEATING AND SHAKING¿. THE PATIENT CLAIMED THEY SELF-TREATED WITH ORANGE JUICE. 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 CONFIRMED THE TES

  Patient problems: Diaphoresis; Hypoglycemia; Shaking/Tremors

  MAUDE report 15442744 ↗
• InjurySep 16, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2022, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THEIR ONETOUCH VERIO2 METER READ INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION AND ON FURTHER INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST AFTER REVIEWING THE CALL RECORDING. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN 3 WEEKS PRIOR TO CONTACTING LFS. THE PATIENT REPORTED OBTAINING WHAT THEY FELT WERE INACCURATE HIGH BLOOD GLUCOSE READINGS OF ¿145, 120, 80, 109, 108, 110, 134 AND 147 MG/DL¿ WITH THE SUBJECT METER ON UNSPECIFIED DATES/TIMES. THE PATIENT MANAGES THEIR DIABETES WITH ORAL MEDICATION (METFORMIN) AND THEY CONTINUED TO FOLLOW THEIR USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT REPORTED THAT ON (B)(6) 2022, BETWEEN 12:30 AND 1:00 PM, THEY EXPERIENCED A ¿LOW SUGAR¿ WITH SYMPTOMS OF ¿SWEATING AND SHAKING¿. THE PATIENT CLAIMED THEY SELF-TREATED WITH ORANGE JUICE. 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 CO

  Patient problems: Diaphoresis; Hypoglycemia; Shaking/Tremors

  MAUDE report 15442741 ↗
• InjurySep 16, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2022, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THEIR ONETOUCH VERIO2 METER READ INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION AND ON FURTHER INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST AFTER REVIEWING THE CALL RECORDING. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN 3 WEEKS PRIOR TO CONTACTING LFS. THE PATIENT REPORTED OBTAINING WHAT THEY FELT WERE INACCURATE HIGH BLOOD GLUCOSE READINGS OF ¿145, 120, 80, 109, 108, 110, 134 AND 147 MG/DL¿ WITH THE SUBJECT METER ON UNSPECIFIED DATES/TIMES. THE PATIENT MANAGES THEIR DIABETES WITH ORAL MEDICATION (METFORMIN) AND THEY CONTINUED TO FOLLOW THEIR USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT REPORTED THAT ON (B)(6) 2022, BETWEEN 12:30 AND 1:00 PM, THEY EXPERIENCED A ¿LOW SUGAR¿ WITH SYMPTOMS OF ¿SWEATING AND SHAKING¿. THE PATIENT CLAIMED THEY SELF-TREATED WITH ORANGE JUICE. 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 CO

  Patient problems: Diaphoresis; Hypoglycemia; Shaking/Tremors

  MAUDE report 15442740 ↗
• InjuryJul 18, 2022Device Handling Problem; Device Handling Problem

  ON JULY 07, 2022, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS), ALLEGING THAT HER ONETOUCH VERIO2 METER READ INACCURATELY LOW COMPARED TO HER NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA) DURING A FOLLOW-UP CALL WITH THE PATIENT. THE PATIENT REPORTED THAT THE ALLEGED ISSUE BEGAN ON (B)(6) 2022 AT ABOUT 6:30 AM, WHEN SHE OBTAINED AN INACCURATE LOW BLOOD GLUCOSE READING OF ¿4.0 MMOL/L¿ WITH THE SUBJECT METER. THE PATIENT MANAGES HER DIABETES WITH INSULIN. DURING THE FOLLOW-UP CALL, THE PATIENT CLAIMED THAT AFTER THE LOW READING WAS OBTAINED SHE DEVELOPED SYMPTOMS OF ¿SWEATING, BLURRY VISION AND PASSING OUT¿. THE PATIENT REPORTED TREATING HERSELF WITH AN EXTRA DEX4 PILL ¿TO PULL UP HER SUGAR¿. THE PATIENT CLAIMED SHE WAS TAKEN TO HOSPITAL LATER THAT DAY WHERE SHE RECEIVED IMMEDIATE TREATMENT AND 5 DAYS LATER, SURGICAL INTERVENTION. DURING THE FOLLOW-UP CALL, THE PATIENT CONFIRMED SHE RECEIVED IMMEDIATE TREATMENT OF A SHOT OF INSULIN AND THAT HER BLOOD GLUCOSE MEASURED ¿ABOUT 9.0 MMOL/L¿ ON THE HOSPITAL METER AFTER TREATMENT. DURING THE FOLLOW-UP CALL, THE PATIENT CLAIMED THE SURGERY SHE HAD WAS FOR A BROKEN FEMU

  Patient problems: Hyperglycemia

  MAUDE report 15048564 ↗
• InjuryJul 18, 2022Device Handling Problem; Device Handling Problem

  ON (B)(6) 2022, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS), ALLEGING THAT HER ONETOUCH VERIO2 METER READ INACCURATELY LOW COMPARED TO HER NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA) DURING A FOLLOW-UP CALL WITH THE PATIENT. THE PATIENT REPORTED THAT THE ALLEGED ISSUE BEGAN ON (B)(6) 2022 AT ABOUT 6:30 AM, WHEN SHE OBTAINED AN INACCURATE LOW BLOOD GLUCOSE READING OF ¿4.0 MMOL/L¿ WITH THE SUBJECT METER. THE PATIENT MANAGES HER DIABETES WITH INSULIN. DURING THE FOLLOW-UP CALL, THE PATIENT CLAIMED THAT AFTER THE LOW READING WAS OBTAINED SHE DEVELOPED SYMPTOMS OF ¿SWEATING, BLURRY VISION AND PASSING OUT¿. THE PATIENT REPORTED TREATING HERSELF WITH AN EXTRA DEX4 PILL ¿TO PULL UP HER SUGAR¿. THE PATIENT CLAIMED SHE WAS TAKEN TO HOSPITAL LATER THAT DAY WHERE SHE RECEIVED IMMEDIATE TREATMENT AND 5 DAYS LATER, SURGICAL INTERVENTION. DURING THE FOLLOW-UP CALL, THE PATIENT CONFIRMED SHE RECEIVED IMMEDIATE TREATMENT OF A SHOT OF INSULIN AND THAT HER BLOOD GLUCOSE MEASURED ¿ABOUT 9.0 MMOL/L¿ ON THE HOSPITAL METER AFTER TREATMENT. DURING THE FOLLOW-UP CALL, THE PATIENT CLAIMED THE SURGERY SHE HAD WAS FOR A BROKEN FEMUR;

  Patient problems: Hyperglycemia

  MAUDE report 15048497 ↗
• InjuryJul 15, 2022Device Handling Problem; Device Handling Problem

  ON (B)(6) 2022, THE PATIENT/LAY USER CONTACTED LIFESCAN (LFS) USA ALLEGING THAT HER ONETOUCH VERIO 2 METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT ALLEGED THAT THE SUBJECT METER HAS BEEN GIVING DIFFERENT READINGS FOR 3 WEEKS PRIOR TO THE CALL WITH LFS. THE PATIENT REPORTED OBTAINING AN ALLEGED INACCURATE HIGH BLOOD GLUCOSE READING OF ¿367 MG/DL¿ WITH THE SUBJECT METER ON (B)(6) 2022 AT 12:39 PM. THE PATIENT MANAGES HER DIABETES WITH PILLS (10 MG GLICLAZIDE) WITH DIET AND/OR EXERCISE AND CLAIMED THAT SHE INCREASED HER MEDICATION WITH ANOTHER DOSE OF 10 MG GLICLAZIDE IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT ALSO INDICATED THAT SHE DRANK WATER. THAT SAME DAY AT 3:20 PM, THE PATIENT DEVELOPED SYMPTOMS OF ¿SHAKING AND FEELING SLEEPY¿ AND SHE OBTAINED ANOTHER READING ON THE SUBJECT METER OF ¿169 MG/DL¿. THE PATIENT DENIED RECEIVING ANY MEDICAL TREATMENT FOR THE REPORTED SYMPTOMS. DURING TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE. HOWEVER, THE PATIENT INFORMED THE CCA THAT THE TEST STRIPS SHE WAS USING WERE EXP

  Patient problems: Lethargy; Shaking/Tremors

  MAUDE report 15033771 ↗
• InjuryJul 15, 2022Device Handling Problem; Device Handling Problem

  ON (B)(6) 2022, THE PATIENT/LAY USER CONTACTED LIFESCAN (LFS) USA ALLEGING THAT HER ONETOUCH VERIO 2 METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT ALLEGED THAT THE SUBJECT METER HAS BEEN GIVING DIFFERENT READINGS FOR 3 WEEKS PRIOR TO THE CALL WITH LFS. THE PATIENT REPORTED OBTAINING AN ALLEGED INACCURATE HIGH BLOOD GLUCOSE READING OF ¿367 MG/DL¿ WITH THE SUBJECT METER ON (B)(6) 2022 AT 12:39 PM. THE PATIENT MANAGES HER DIABETES WITH PILLS (10 MG GLICLAZIDE) WITH DIET AND/OR EXERCISE AND CLAIMED THAT SHE INCREASED HER MEDICATION WITH ANOTHER DOSE OF 10 MG GLICLAZIDE IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT ALSO INDICATED THAT SHE DRANK WATER. THAT SAME DAY AT 3:20 PM, THE PATIENT DEVELOPED SYMPTOMS OF ¿SHAKING AND FEELING SLEEPY¿ AND SHE OBTAINED ANOTHER READING ON THE SUBJECT METER OF ¿169 MG/DL¿. THE PATIENT DENIED RECEIVING ANY MEDICAL TREATMENT FOR THE REPORTED SYMPTOMS. DURING TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE. HOWEVER, THE PATIENT INFORMED THE CCA THAT THE TEST STRIPS SHE WAS USING WERE EXP

  Patient problems: Lethargy; Shaking/Tremors

  MAUDE report 15033769 ↗
• InjuryMay 26, 2022Device Handling Problem; Device Handling Problem

  ON MAY 19, 2022, A REPORTER FOR THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO2 METER READ INACCURATELY HIGH COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED METER INACCURACY OCCURRED IN (B)(6) 2020. THE REPORTER CLAIMED THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT WHICH WAS ¿HIGHER THAN USUAL¿ WITH THE SUBJECT METER THEN A BLOOD GLUCOSE RESULT WHICH WAS ¿LOW¿ ON AN UNSPECIFIED EMERGENCY ROOM (ER) METER; EXACT RESULTS WERE NOT PROVIDED. THE TESTS WERE PERFORMED MORE THAN 30 MINUTES APART. THE PATIENT MANAGES THEIR DIABETES WITH INSULIN ON A SELF-ADJUSTING DOSE. THE REPORTER CLAIMED THE PATIENT TOOK MORE INSULIN IN RESPONSE TO THE ELEVATED READING OBTAINED WITH THE SUBJECT METER THEN STARTED TO DEVELOP SYMPTOMS OF ¿BLURRY VISION, WEAK AND EMOTIONAL¿. THE REPORTER CLAIMED THE PATIENT PROCEEDED TO THE ER WHERE THEY OBTAINED A BLOOD GLUCOSE RESULT WHICH WAS ¿LOW¿ ON THE ER METER AND WERE TREATED WITH FOOD AND DRINK. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT AN APPROVED SAMPLE SITE WAS USED FOR TESTING. REPLACEMENT PRODUCT WAS

  Patient problems: Blurred Vision; Emotional Changes; Fatigue; Hypoglycemia

  MAUDE report 14504595 ↗
• InjuryMay 26, 2022Device Handling Problem; Device Handling Problem

  ON MAY 19, 2022, A REPORTER FOR THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO2 METER READ INACCURATELY HIGH COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED METER INACCURACY OCCURRED IN (B)(6) 2020. THE REPORTER CLAIMED THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT WHICH WAS ¿HIGHER THAN USUAL¿ WITH THE SUBJECT METER THEN A BLOOD GLUCOSE RESULT WHICH WAS ¿LOW¿ ON AN UNSPECIFIED EMERGENCY ROOM (ER) METER; EXACT RESULTS WERE NOT PROVIDED. THE TESTS WERE PERFORMED MORE THAN 30 MINUTES APART. THE PATIENT MANAGES THEIR DIABETES WITH INSULIN ON A SELF-ADJUSTING DOSE. THE REPORTER CLAIMED THE PATIENT TOOK MORE INSULIN IN RESPONSE TO THE ELEVATED READING OBTAINED WITH THE SUBJECT METER THEN STARTED TO DEVELOP SYMPTOMS OF ¿BLURRY VISION, WEAK AND EMOTIONAL¿. THE REPORTER CLAIMED THE PATIENT PROCEEDED TO THE ER WHERE THEY OBTAINED A BLOOD GLUCOSE RESULT WHICH WAS ¿LOW¿ ON THE ER METER AND WERE TREATED WITH FOOD AND DRINK. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT AN APPROVED SAMPLE SITE WAS USED FOR TESTING. REPLACEMENT PRODUCT WAS

  Patient problems: Blurred Vision; Emotional Changes; Fatigue; Hypoglycemia

  MAUDE report 14504520 ↗
• InjuryMay 9, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2022, LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THEIR ONETOUCH VERIO2 METER WAS READING INACCURATELY COMPARED TO THEIR FEELINGS AND/OR NORMAL RESULTS. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL AND ADDITIONAL INFORMATION OBTAINED WHEN THE MEDICAL SURVEILLANCE SPECIALIST (MSS) LISTENED TO THE CALL RECORDING. THE PATIENT WAS UNABLE TO RECALL THE DATE/TIME THAT THE ALLEGED INACCURACY ISSUE BEGAN; HOWEVER, STATED IT WAS APPROXIMATELY 3 MONTHS PRIOR TO CONTACTING LIFESCAN. THE PATIENT WAS UNABLE TO RECALL EXACT RESULTS OBTAINED; HOWEVER, ADVISED THE CCA THAT THE RESULTS WERE ¿SOMETIMES TOO HIGH OR SOMETIMES TOO LOW.¿ THE PATIENT MANAGES THEIR DIABETES WITH ORAL MEDICATION (METFORMIN, UNSPECIFIED DOSE) AND DENIED MAKING ANY CHANGES TO THEIR USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE; ADVISING THAT THEY CONTINUED TO TAKE THEIR ORAL MEDICATION AS PRESCRIBED. THE PATIENT REPORTED DURING THE CALL THAT ON AN UNSPECIFIED DATE AFTER THE ALLEGED INACCURACY ISSUE BEGAN, THEY DEVELOPED SYMPTOMS OF FEELING ¿SHAKY¿ AND THAT THEY HAD ¿COLD SWEATS¿. THE PATIENT REPORTED THAT

  Patient problems: Diaphoresis; Shaking/Tremors

  MAUDE report 14335946 ↗
• InjuryMay 9, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2022, LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THEIR ONETOUCH VERIO2 METER WAS READING INACCURATELY COMPARED TO THEIR FEELINGS AND/OR NORMAL RESULTS. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL AND ADDITIONAL INFORMATION OBTAINED WHEN THE MEDICAL SURVEILLANCE SPECIALIST (MSS) LISTENED TO THE CALL RECORDING. THE PATIENT WAS UNABLE TO RECALL THE DATE/TIME THAT THE ALLEGED INACCURACY ISSUE BEGAN; HOWEVER, STATED IT WAS APPROXIMATELY 3 MONTHS PRIOR TO CONTACTING LIFESCAN. THE PATIENT WAS UNABLE TO RECALL EXACT RESULTS OBTAINED; HOWEVER, ADVISED THE CCA THAT THE RESULTS WERE ¿SOMETIMES TOO HIGH OR SOMETIMES TOO LOW.¿ THE PATIENT MANAGES THEIR DIABETES WITH ORAL MEDICATION (METFORMIN, UNSPECIFIED DOSE) AND DENIED MAKING ANY CHANGES TO THEIR USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE; ADVISING THAT THEY CONTINUED TO TAKE THEIR ORAL MEDICATION AS PRESCRIBED. THE PATIENT REPORTED DURING THE CALL THAT ON AN UNSPECIFIED DATE AFTER THE ALLEGED INACCURACY ISSUE BEGAN, THEY DEVELOPED SYMPTOMS OF FEELING ¿SHAKY¿ AND THAT THEY HAD ¿COLD SWEATS¿. THE PATIENT REPORTED THAT

  Patient problems: Diaphoresis; Shaking/Tremors

  MAUDE report 14335925 ↗
• InjuryFeb 10, 2022Device Displays Incorrect Message; Device Displays Incorrect Message

  ON (B)(6) 2022, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH VERIO 2 METER WAS DISPLAYING AN UNKNOWN ERROR MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ERROR MESSAGE BEGAN TO APPEAR ON (B)(6) 2022, AT 12:30 PM. THE PATIENT MANAGES HER DIABETES WITH INSULIN (FIXED DOSE) AND STATED THAT SHE FELT UNSURE ON HOW MANY UNITS OF INSULIN TO TAKE DUE TO THE ALLEGED ISSUE. THE PATIENT CLAIMED THAT AFTER THE ALLEGED ISSUE OCCURRED, SHE REDUCED HER INSULIN INTAKE FROM 12 TO 6 UNITS IN RESPONSE TO THE ALLEGED ISSUE AT 12:30 PM. THE PATIENT STARTED DEVELOPING SYMPTOMS OF ¿SHAKINESS AND DIZZINESS¿ AT 1 PM. THE PATIENT DENIED RECEIVING ANY MEDICAL TREATMENT FOR THE REPORTED SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME. THE CCA WALKED THE PATIENT THROUGH A RETEST AND THE ALLEGED ISSUE REMAINED UNRESOLVED. THE CCA CONCLUDED THAT THE ERROR MESSAGE WAS CAUSED BY THE SYSTEM. A REPLACEMENT METER WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A

  Patient problems: Dizziness; Shaking/Tremors

  MAUDE report 13510285 ↗