OneTouch VerioRecalls & reported problems across all models
LifeScan Europe GmbH · 7 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4,433
- Deaths reported
- 0
- Injuries reported
- 354
- Recalls
- 0
We found 7 models of OneTouch Verio by LifeScan Europe GmbH in the FDA's device registry (GUDID). Together they are named in 4,433 adverse event reports in the FDA's MAUDE database, received between Nov 22, 2016 and Oct 28, 2025 — classified as 354 injuries, 4,078 malfunctions.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (2,079 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 problems
Device problems
- Device Displays Incorrect Message2,079
- Incorrect Or Inadequate Test Results599
- Incorrect, Inadequate or Imprecise Result or Readings457
- Device Alarm System351
- Loss of Power323
- Appropriate Device Problem Term/Code Not Available163
- Device Damaged Prior to Use58
- Adverse Event Without Identified Device or Use Problem43
Patient problems
- No Consequences Or Impact To Patient4,076
- Shaking/Tremors117
- Dizziness95
- Sweating90
- Hypoglycemia41
- Confusion/ Disorientation32
- Headache31
- Blurred Vision27
OneTouch Verio models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OneTouch Verio 022-659Glucose dehydrogenase, glucose4,219 reports
- OneTouch Verio 022-898Glucose dehydrogenase, glucose78 reports
- OneTouch Verio 022-899Glucose dehydrogenase, glucose63 reports
- OneTouch Verio 022-657SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER37 reports
- OneTouch Verio 022-658SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER21 reports
- OneTouch Verio 022-269SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER13 reports
- OneTouch Verio 024-269System, Test, Blood Glucose, Over The Counter2 reports
Recent OneTouch Verio adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryOct 28, 2025Use of Device Problem; Use of Device Problem
ON (B)(6) 2025, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING A PRODUCT USABILITY ISSUE WITH THEIR ONE TOUCH VERIO TEST STRIPS. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL. THE PATIENT REPORTED THAT THE ALLEGED ISSUE OCCURRED AT AROUND 7:30 A.M., ON (B)(6) 2025. THE PATIENT MANAGES THEIR DIABETES WITH ORAL MEDICATION (METFORMIN, 500 MG IN THE EVENING; FARXIGA, 5 MG DAILY AND, GLYBURIDE, 5 MG TWICE DAILY). THE PATIENT ADVISED THAT THEY WOKE UP AND ¿ACCIDENTALLY INGESTED SOME STRIPS¿, APPROXIMATELY ¿7 TO 10¿ TEST STRIPS AS THEY HAD CONFUSED THE TEST STRIP VIAL WITH A MEDICINE BOTTLE. THE PATIENT ADVISED THAT IN RESPONSE TO INGESTING THE TEST STRIPS, THEY ATTEMPTED TO VOMIT AND ATE A SMALL PIECE OF BREAD. THE PATIENT REPORTED THAT THEY NOTICED THAT THEIR ¿PHLEGM FELT DIFFERENT ¿ NOT NORMAL¿ AND DESCRIBED HAVING A ¿METALLIC AND CHEMICAL¿ TASTE. THE PATIENT WENT TO THE EMERGENCY ROOM AT AROUND 9 A.M., ON (B)(6) 2025, WHERE THEY RECEIVED IV FLUIDS, WERE PLACED ON CARDIAC MONITORING, HAD SOME LAB SAMPLES TAKEN AND HAD A CHEST X-RAY. THE PATIENT REQUESTED TEST STRIP INFORMATION WHICH THE CCA PROVIDED. TH
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23402955 ↗InjuryOct 28, 2025Use of Device Problem; Use of Device Problem
ON (B)(6) 2025, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING A PRODUCT USABILITY ISSUE WITH THEIR ONE TOUCH VERIO TEST STRIPS. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL. THE PATIENT REPORTED THAT THE ALLEGED ISSUE OCCURRED AT AROUND 7:30 A.M., ON (B)(6) 2025. THE PATIENT MANAGES THEIR DIABETES WITH ORAL MEDICATION (METFORMIN, 500 MG IN THE EVENING; FARXIGA, 5 MG DAILY AND, GLYBURIDE, 5 MG TWICE DAILY). THE PATIENT ADVISED THAT THEY WOKE UP AND ¿ACCIDENTALLY INGESTED SOME STRIPS¿, APPROXIMATELY ¿7 TO 10¿ TEST STRIPS AS THEY HAD CONFUSED THE TEST STRIP VIAL WITH A MEDICINE BOTTLE. THE PATIENT ADVISED THAT IN RESPONSE TO INGESTING THE TEST STRIPS, THEY ATTEMPTED TO VOMIT AND ATE A SMALL PIECE OF BREAD. THE PATIENT REPORTED THAT THEY NOTICED THAT THEIR ¿PHLEGM FELT DIFFERENT ¿ NOT NORMAL¿ AND DESCRIBED HAVING A ¿METALLIC AND CHEMICAL¿ TASTE. THE PATIENT WENT TO THE EMERGENCY ROOM AT AROUND 9 A.M., ON (B)(6) 2025, WHERE THEY RECEIVED IV FLUIDS, WERE PLACED ON CARDIAC MONITORING, HAD SOME LAB SAMPLES TAKEN AND HAD A CHEST X-RAY. THE PATIENT REQUESTED TEST STRIP INFORMATION WHICH THE CCA PROVIDED. TH
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23402907 ↗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 14, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON JUNE 09, 2023, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) PORTUGAL, ALLEGING THAT HIS ONETOUCH VERIO 2 METER WAS READING INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL. THE PATIENT ALLEGED THAT THE ISSUE STARTED ON (B)(6) 2023, WHEN HE RECEIVED THREE BLOOD GLUCOSE READINGS, BEFORE AND AFTER DINNER, ALL ABOVE ¿240 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT INDICATED THAT HE FELT THAT THE READINGS WERE NOT ACCURATE BUT DUE TO A HEART SURGERY RECENTLY, HE TRUSTED THE RESULTS. THE PATIENT MANAGES HIS DIABETES WITH UNSPECIFIED INSULIN (SELF-ADJUSTING DOSE ¿ USUAL DOSE BETWEEN 14-16 UNITS) AND CLAIMED THAT HE INCREASED HIS INSULIN INTAKE TO 20 UNITS AT 11 PM IN RESPONSE TO THE HIGH READINGS. DURING HIS SLEEP THE PATIENT WOKE BETWEEN 11:30 PM AND 12 AM TO USE THE BATHROOM AND STARTED FEELING ¿DIZZY AND FAINTED¿. THE PATIENT¿S WIFE ASSISTED HIM PROMPTLY AND TREATED HIM IMMEDIATELY WITH SUGAR PACKETS. THE PATIENT INDICATED THAT HE STARTED TO FEEL NORMAL AFTER. DURING TROUBLESHOOTING, THE CCA WAS NOT ABLE TO CONFIRM IF THE UNIT OF MEASURE WAS SET CO
Patient problems: Dizziness; Syncope/Fainting
MAUDE report 17131860 ↗InjuryJun 14, 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) PORTUGAL, ALLEGING THAT HIS ONETOUCH VERIO 2 METER WAS READING INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL. THE PATIENT ALLEGED THAT THE ISSUE STARTED ON (B)(6) 2023, WHEN HE RECEIVED THREE BLOOD GLUCOSE READINGS, BEFORE AND AFTER DINNER, ALL ABOVE ¿240 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT INDICATED THAT HE FELT THAT THE READINGS WERE NOT ACCURATE BUT DUE TO A HEART SURGERY RECENTLY, HE TRUSTED THE RESULTS. THE PATIENT MANAGES HIS DIABETES WITH UNSPECIFIED INSULIN (SELF-ADJUSTING DOSE ¿ USUAL DOSE BETWEEN 14-16 UNITS) AND CLAIMED THAT HE INCREASED HIS INSULIN INTAKE TO 20 UNITS AT 11 PM IN RESPONSE TO THE HIGH READINGS. DURING HIS SLEEP THE PATIENT WOKE BETWEEN 11:30 PM AND 12 AM TO USE THE BATHROOM AND STARTED FEELING ¿DIZZY AND FAINTED¿. THE PATIENT¿S WIFE ASSISTED HIM PROMPTLY AND TREATED HIM IMMEDIATELY WITH SUGAR PACKETS. THE PATIENT INDICATED THAT HE STARTED TO FEEL NORMAL AFTER. DURING TROUBLESHOOTING, THE CCA WAS NOT ABLE TO CONFIRM IF THE UNIT OF MEASURE WAS SET CORR
Patient problems: Dizziness; Syncope/Fainting
MAUDE report 17131859 ↗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 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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