OneTouch Verio FlexRecalls & reported problems across all models
LifeScan Europe GmbH · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3,739
- Deaths reported
- 0
- Injuries reported
- 642
- Recalls
- 0
We found 5 models of OneTouch Verio Flex by LifeScan Europe GmbH in the FDA's device registry (GUDID). Together they are named in 3,739 adverse event reports in the FDA's MAUDE database, received between Nov 18, 2016 and Sep 29, 2026 — classified as 642 injuries, 3,097 malfunctions.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (1,414 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 Flex problems
Device problems
- Device Displays Incorrect Message1,414
- Incorrect, Inadequate or Imprecise Result or Readings645
- Incorrect Or Inadequate Test Results488
- Loss of Power321
- Device Alarm System226
- Low Battery226
- Appropriate Device Problem Term/Code Not Available99
- Adverse Event Without Identified Device or Use Problem57
Patient problems
- No Consequences Or Impact To Patient3,068
- Shaking/Tremors221
- Dizziness152
- Sweating91
- Hypoglycemia76
- Diaphoresis74
- Fatigue66
- Headache66
OneTouch Verio Flex models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OneTouch Verio Flex 023-271SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER3,703 reports
- OneTouch Verio Flex 023-270SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER14 reports
- OneTouch Verio Flex 024044System, Test, Blood Glucose, Over The Counter11 reports
- OneTouch Verio Flex 023-194SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER9 reports
- OneTouch Verio Flex 024-267Glucose Dehydrogenase, Glucose2 reports
Recent OneTouch Verio Flex adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Device Displays Incorrect Message
Patient problems: Fatigue; Hypoglycemia; Loss of consciousness
MAUDE report 50926761 ↗InjurySep 29, 2026Device Displays Incorrect Message
Patient problems: Fatigue; Hypoglycemia; Loss of consciousness
MAUDE report 50926758 ↗InjuryAug 21, 2026Incorrect, Inadequate or Imprecise Result or Readings
On (b)(6) 2026, the patient contacted LifeScan (LFS), alleging that their OneTouch Verio Flex meter read inaccurately high compared to another meter. The complaint was classified based on the Customer Care Agent (CCA) documentation, since the patient was unable to be reached by phone for additional information. It was not reported when the alleged meter inaccuracy began. The patient claimed obtaining a blood glucose reading of ¿161 mg/dL¿ with the subject meter compared to an unspecified reading on another OneTouch meter. It was not reported if the patient took any action regarding their usual diabetes management as a result of the alleged issue. The patient reported that they were hospitalized for a week because their ¿sugar dropped¿, claiming the subject meter was displaying high readings when they were low. No further event details were provided. It was not reported what treatment the patient received.At the time of troubleshooting, the CCA noted 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 not have control solution available to perform a quality control test. T
Patient problems: Hypoglycemia
MAUDE report 50360201 ↗InjuryMar 23, 2026Device Displays Incorrect Message
ON FEBRUARY 26, 2026, THE LAY USER/PATIENT¿S SPOUSE CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THAT THE PATIENT¿S ONETOUCH VERIO FLEX METER WAS DISPLAYING AN ¿ERROR 2¿ MESSAGE DURING TESTING. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION, SINCE ATTEMPTS TO REACH THE REPORTER FOR FURTHER INFORMATION WERE UNSUCCESSFUL. THE REPORTER STATED THAT ON FEBRUARY 25, 2026, AT 1:30 AM, THE PATIENT WAS SLEEPING AND WHEN SHE ATTEMPTED TO WAKE HIM, HE WAS ¿UNRESPONSIVE¿, AND AN ¿ERROR 2¿ MESSAGE APPEARED WHEN ATTEMPTING TO TEST HIS BLOOD GLUCOSE WITH THE SUBJECT METER. THE REPORTER STATED THAT SHE CALLED EMERGENCY MEDICAL SERVICES (EMS) FOR ASSISTANCE. WHEN EMS ARRIVED, THE REPORTER CLAIMED THAT THEY TESTED THE PATIENT¿S BLOOD GLUCOSE ON THE EMS METER (UNSPECIFIED RESULT) AND PROVIDED UNSPECIFIED TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME. THE CCA WALKED THROUGH RESOLVING THE ISSUE HOWEVER THE ALLEGED ISSUE COULD NOT BE RESOLVED. A REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY RECEIVED MEDICAL INTERVENTION FOR A POSSIB
Patient problems: Loss of consciousness
MAUDE report 24662923 ↗InjuryMar 23, 2026Device Displays Incorrect Message
ON (B)(6) 2026, THE LAY USER/PATIENT¿S SPOUSE CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THAT THE PATIENT¿S ONETOUCH VERIO FLEX METER WAS DISPLAYING AN ¿ERROR 2¿ MESSAGE DURING TESTING. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION, SINCE ATTEMPTS TO REACH THE REPORTER FOR FURTHER INFORMATION WERE UNSUCCESSFUL. THE REPORTER STATED THAT ON (B)(6) 2026, AT 1:30 AM, THE PATIENT WAS SLEEPING AND WHEN SHE ATTEMPTED TO WAKE HIM, HE WAS ¿UNRESPONSIVE¿, AND AN ¿ERROR 2¿ MESSAGE APPEARED WHEN ATTEMPTING TO TEST HIS BLOOD GLUCOSE WITH THE SUBJECT METER. THE REPORTER STATED THAT SHE CALLED EMERGENCY MEDICAL SERVICES (EMS) FOR ASSISTANCE. WHEN EMS ARRIVED, THE REPORTER CLAIMED THAT THEY TESTED THE PATIENT¿S BLOOD GLUCOSE ON THE EMS METER (UNSPECIFIED RESULT) AND PROVIDED UNSPECIFIED TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME. THE CCA WALKED THROUGH RESOLVING THE ISSUE HOWEVER THE ALLEGED ISSUE COULD NOT BE RESOLVED. A REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY RECEIVED MEDICAL INTERVENTION FOR A POSSIBLE ACUTE COM
Patient problems: Loss of consciousness
MAUDE report 24662915 ↗InjuryNov 4, 2025Power Problem; Power Problem
ON (B)(6) 2025, A REPORTER FOR THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO FLEX METER WOULD TURN OFF DURING USE AND NO LONGER TURNS ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED POWER ISSUE BEGAN 3 MONTHS AGO. THE PATIENT MANAGES THEIR DIABETES WITH ORAL MEDICATION (METFORMIN 1000 MG) AND INSULIN (NOVOLOG/DOSE UNSPECIFIED). THE REPORTER DENIED THE PATIENT MADE ANY CHANGES TO THEIR USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED ISSUE. THE REPORTER STATED THAT ON (B)(6) 2025, AT 2:00 AM, THE PATIENT BECAME ¿UNCONSCIOUS¿ AND WAS TREATED BY EMERGENCY MEDICAL SERVICES (EMS) WITH IV GLUCOSE AND AN UNSPECIFIED INJECTION. PRIOR TO RECEIVING TREATMENT, THE REPORTER CLAIMED THAT THE PATIENT¿S BLOOD GLUCOSE WAS MEASURED ON THE EMS METER AND A RESULT OF ¿43 MG/DL¿ WAS OBTAINED. 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 NOTED THAT THE METER WOULD NOT POWER ON MANUALLY WHEN THE POWER BUTTON WAS PRESSED OR WHEN A TEST
Patient problems: Hypoglycemia; Syncope/Fainting
MAUDE report 23472442 ↗InjuryNov 4, 2025Power Problem; Power Problem
ON OCTOBER 27, 2025, A REPORTER FOR THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO FLEX METER WOULD TURN OFF DURING USE AND NO LONGER TURNS ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED POWER ISSUE BEGAN 3 MONTHS AGO. THE PATIENT MANAGES THEIR DIABETES WITH ORAL MEDICATION (METFORMIN 1000 MG) AND INSULIN (NOVOLOG/DOSE UNSPECIFIED). THE REPORTER DENIED THE PATIENT MADE ANY CHANGES TO THEIR USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED ISSUE. THE REPORTER STATED THAT ON (B)(6) 2025, AT 2:00 AM, THE PATIENT BECAME ¿UNCONSCIOUS¿ AND WAS TREATED BY EMERGENCY MEDICAL SERVICES (EMS) WITH IV GLUCOSE AND AN UNSPECIFIED INJECTION. PRIOR TO RECEIVING TREATMENT, THE REPORTER CLAIMED THAT THE PATIENT¿S BLOOD GLUCOSE WAS MEASURED ON THE EMS METER AND A RESULT OF ¿43 MG/DL¿ WAS OBTAINED. 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 NOTED THAT THE METER WOULD NOT POWER ON MANUALLY WHEN THE POWER BUTTON WAS PRESSED OR WHEN A
Patient problems: Hypoglycemia; Syncope/Fainting
MAUDE report 23472441 ↗InjuryOct 15, 2025Device Handling Problem; Device Handling Problem
ON (B)(6) 2025, THE SPOUSE OF A LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA. THE REPORTER ALLEGED THAT THE PATIENT RECEIVED AN INACCURATE HIGH CONTROL SOLUTION RESULT IN ADDITION TO ALLEGING THAT THEIR ONETOUCH VERIO FLEX METER WAS GENERATING INACCURATELY HIGH RESULTS COMPARED TO HIS FEELING/NORMAL RESULTS AND COMPARED TO HIS CONTINUOUS GLUCOSE MONITOR. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED ISSUE BEGAN ALMOST TWO MONTHS PRIOR, AT AN UNSPECIFIED DATE. ON AN UNSPECIFIED DATE, THE PATIENT OBTAINED A GLUCOSE READING OF 249 MG/DL, WHICH WAS CONSIDERED UNUSUALLY HIGH FOR HIM COMPARED TO HIS FEELING/NORMAL RESULTS AND WITHIN 2 MINUTES WAS COMPARED TO HIS DEXCOM CONTINUOUS GLUCOSE MONITOR GLUCOSE READING OF 110 MG/DL. IN ADDITION TO THIS, THE REPORTER ALLEGED THAT ON AN UNSPECIFIED DATE, THE PATIENT RECEIVED AN INACCURATE HIGH CONTROL SOLUTION RESULT OF 404MG/DL. THE PATIENT MANAGES THEIR DIABETES WITH THE FOLLOWING MEDICATION: LANTUS - 26 UNITS, SHORT-ACTING INSULIN 12 UNITS BEFORE EVERY MEAL, METFORMIN TWO TABLETS OF UNSPECIFIED DOSAGE. THE PATIENT DID NOT MAKE ANY CHANGES TO THEIR MEDICATION IN RESPONSE
Patient problems: Syncope/Fainting
MAUDE report 23299946 ↗InjuryOct 15, 2025Device Handling Problem; Device Handling Problem
ON (B)(6) 2025, THE SPOUSE OF A LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA. THE REPORTER ALLEGED THAT THE PATIENT RECEIVED AN INACCURATE HIGH CONTROL SOLUTION RESULT IN ADDITION TO ALLEGING THAT THEIR ONETOUCH VERIO FLEX METER WAS GENERATING INACCURATELY HIGH RESULTS COMPARED TO HIS FEELING/NORMAL RESULTS AND COMPARED TO HIS CONTINUOUS GLUCOSE MONITOR. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED ISSUE BEGAN ALMOST TWO MONTHS PRIOR, AT AN UNSPECIFIED DATE. ON AN UNSPECIFIED DATE, THE PATIENT OBTAINED A GLUCOSE READING OF 249 MG/DL, WHICH WAS CONSIDERED UNUSUALLY HIGH FOR HIM COMPARED TO HIS FEELING/NORMAL RESULTS AND WITHIN 2 MINUTES WAS COMPARED TO HIS DEXCOM CONTINUOUS GLUCOSE MONITOR GLUCOSE READING OF 110 MG/DL. IN ADDITION TO THIS, THE REPORTER ALLEGED THAT ON AN UNSPECIFIED DATE, THE PATIENT RECEIVED AN INACCURATE HIGH CONTROL SOLUTION RESULT OF 404MG/DL. THE PATIENT MANAGES THEIR DIABETES WITH THE FOLLOWING MEDICATION: LANTUS - 26 UNITS, SHORT-ACTING INSULIN 12 UNITS BEFORE EVERY MEAL, METFORMIN TWO TABLETS OF UNSPECIFIED DOSAGE. THE PATIENT DID NOT MAKE ANY CHANGES TO THEIR MEDICATION IN RESPONSE
Patient problems: Syncope/Fainting
MAUDE report 23286844 ↗InjurySep 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6) 2025, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT HER ONETOUCH VERIO FLEX METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS AND COMPARED TO ANOTHER METER (RELION), AND TO A CONTINUOUS GLUCOSE MONITORING (CGM) DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN ON THE MORNING OF (B)(6) 2025, AT AROUND 10:00 AM. THE PATIENT REPORTED OBTAINING WHAT SHE FELT WAS AN INACCURATE HIGH BLOOD GLUCOSE READING OF ¿197 MG/DL¿ WITH THE SUBJECT METER AND COMPARED THE METER READING TO AN UNSPECIFIED READING OBTAINED ON HER OTHER METER THEN TO A READING OF ¿137 MG/DL¿ OBTAINED ON HER CGM DEVICE. THE PATIENT MANAGES HER DIABETES WITH INSULIN LISPRO ON A SELF-ADJUSTING DOSE. THE PATIENT STATED THAT BASED ON THE HIGH READING OF ¿197 MG/DL¿, SHE TOOK AN INCREASED DOSE OF INSULIN ACCORDING TO HER DOCTOR¿S RECOMMENDATION. 1 HOUR LATER, THE PATIENT REPORTED HAVING A LOW BLOOD GLUCOSE EPISODE WITH SYMPTOMS OF ¿FEELING BAD, SWEATY, DIZZY AND LIKE PASSING OUT¿. THE PATIENT REPORTED TREATING HERSELF USING BAQSIMI (GLUCAGON NASAL SPRAY) TO RAISE
Patient problems: Diaphoresis; Dizziness; Hypoglycemia; Malaise; Presyncope
MAUDE report 22974290 ↗InjurySep 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON AUGUST 27, 2025, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT HER ONETOUCH VERIO FLEX METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS AND COMPARED TO ANOTHER METER (RELION), AND TO A CONTINUOUS GLUCOSE MONITORING (CGM) DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN ON THE MORNING OF (B)(6) 2025, AT AROUND 10:00 AM. THE PATIENT REPORTED OBTAINING WHAT SHE FELT WAS AN INACCURATE HIGH BLOOD GLUCOSE READING OF ¿197 MG/DL¿ WITH THE SUBJECT METER AND COMPARED THE METER READING TO AN UNSPECIFIED READING OBTAINED ON HER OTHER METER THEN TO A READING OF ¿137 MG/DL¿ OBTAINED ON HER CGM DEVICE. THE PATIENT MANAGES HER DIABETES WITH INSULIN LISPRO ON A SELF-ADJUSTING DOSE. THE PATIENT STATED THAT BASED ON THE HIGH READING OF ¿197 MG/DL¿, SHE TOOK AN INCREASED DOSE OF INSULIN ACCORDING TO HER DOCTOR¿S RECOMMENDATION. 1 HOUR LATER, THE PATIENT REPORTED HAVING A LOW BLOOD GLUCOSE EPISODE WITH SYMPTOMS OF ¿FEELING BAD, SWEATY, DIZZY AND LIKE PASSING OUT¿. THE PATIENT REPORTED TREATING HERSELF USING BAQSIMI (GLUCAGON NASAL SPRAY) TO R
Patient problems: Diaphoresis; Dizziness; Hypoglycemia; Malaise; Presyncope
MAUDE report 22974289 ↗InjuryApr 18, 2025Power Problem; Power Problem
ON (B)(6) 2025, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THEIR ONETOUCH VERIO METER WOULD NOT TURN ON. 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 LISTENED TO THE CALL RECORDING. THE PATIENT COULD NOT BE REACHED FOR FOLLOW-UP. THE PATIENT REPORTED THAT THE ALLEGED ISSUE BEGAN AT AN UNSPECIFIED DATE/TIME APPROXIMATELY 2 WEEKS PRIOR TO CONTACTING LFS. THE PATIENT MANAGES THEIR DIABETES WITH INSULIN (LANTUS INSULIN LONG ACTING 10 UNITS PER DAY AND HUMALOG, SELF-ADJUSTED 8 ¿ 10 UNITS 3 TIMES PER DAY) AND THEY ADVISED THAT THEY CONTINUED TO ADMINISTER THEIR USUAL DOSE OF MEDICATION IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT ALLEGED THAT AT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE BEGAN, THEY ¿LOST CONSCIOUSNESS¿, WHICH THEY ATTRIBUTED TO NOT BEING ABLE TO OBTAIN A GLUCOSE READING. THE PATIENT REPORTED DURING THE CALL THAT THEY CALLED AN AMBULANCE AND WERE TAKEN TO HOSPITAL WHERE THEY RECEIVED MEDICAL INTERVENTION AS A RESULT OF THE ALLEGED ISSUE; HOWEVER, THEY WERE UNABLE AND/OR UNWILLING TO PROVID
Patient problems: Loss of consciousness
MAUDE report 21863604 ↗InjuryApr 18, 2025Power Problem; Power Problem
ON (B)(6) 2025, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THEIR ONETOUCH VERIO METER WOULD NOT TURN ON. 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 LISTENED TO THE CALL RECORDING. THE PATIENT COULD NOT BE REACHED FOR FOLLOW-UP. THE PATIENT REPORTED THAT THE ALLEGED ISSUE BEGAN AT AN UNSPECIFIED DATE/TIME APPROXIMATELY 2 WEEKS PRIOR TO CONTACTING LFS. THE PATIENT MANAGES THEIR DIABETES WITH INSULIN (LANTUS INSULIN LONG ACTING 10 UNITS PER DAY AND HUMALOG, SELF-ADJUSTED 8 ¿ 10 UNITS 3 TIMES PER DAY) AND THEY ADVISED THAT THEY CONTINUED TO ADMINISTER THEIR USUAL DOSE OF MEDICATION IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT ALLEGED THAT AT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE BEGAN, THEY ¿LOST CONSCIOUSNESS¿, WHICH THEY ATTRIBUTED TO NOT BEING ABLE TO OBTAIN A GLUCOSE READING. THE PATIENT REPORTED DURING THE CALL THAT THEY CALLED AN AMBULANCE AND WERE TAKEN TO HOSPITAL WHERE THEY RECEIVED MEDICAL INTERVENTION AS A RESULT OF THE ALLEGED ISSUE; HOWEVER, THEY WERE UNABLE AND/OR UNWILLING TO PROVID
Patient problems: Loss of consciousness
MAUDE report 21863562 ↗InjuryMar 26, 2025Device Alarm System; Device Displays Incorrect Message; Power Problem; Device Alarm System; Device Displays Incorrect Message; Power Problem
ON (B)(6) 2025, THE REPORTER OF THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO FLEX METER DISPLAYED AN UNKNOWN ERROR MESSAGE, CONTINUED DISPLAYING ¿APPLY BLOOD¿ AFTER APPLYING A BLOOD SAMPLE AND POWERED OFF DURING USE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION SINCE THE PATIENT COULD NOT BE REACHED BY PHONE FOR FOLLOW-UP QUESTIONS. THE REPORTER ALLEGED THAT THE ISSUES OCCURRED ON (B)(6) 2025, AT AN UNSPECIFIED TIME. THE PATIENT MANAGES THEIR DIABETES WITH A COMBINATION OF MEDICATION (LANTUS INSULIN 19 UNITS AND GLIPIZIDE ¿ 1 TABLET TWICE A DAY) AND THE REPORTER DENIED THAT THE PATIENT TOOK ANY ACTION IN RESPONSE TO THE ALLEGED ISSUES. THAT SAME DAY, AT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT WAS ¿SHAKING, HAD A CONVULSION, WAS DIZZY AND DID NOT KNOW WHERE THEY WERE¿. THAT SAME DAY, AROUND 8 O¿CLOCK (AM OR PM WAS NOT SPECIFIED), THE PARAMEDICS WERE CALLED AND A BLOOD GLUCOSE READING OF ¿40 MG/DL¿ WAS OBTAINED ON AN EMERGENCY MEDICAL SERVICES (EMS) METER INDICATING THE PATIENT WAS ¿HYPOGLYCEMIC¿. THE REPORTER IS UNSURE WHETHER THE PARAMEDICS PROVIDED THE PATIENT WITH ANY T
Patient problems: Confusion/ Disorientation; Convulsion/Seizure; Dizziness; Hypoglycemia; Shaking/Tremors
MAUDE report 21704315 ↗InjuryMar 26, 2025Device Alarm System; Device Displays Incorrect Message; Power Problem; Device Alarm System; Device Displays Incorrect Message; Power Problem
ON (B)(6) 2025, THE REPORTER OF THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO FLEX METER DISPLAYED AN UNKNOWN ERROR MESSAGE, CONTINUED DISPLAYING ¿APPLY BLOOD¿ AFTER APPLYING A BLOOD SAMPLE AND POWERED OFF DURING USE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION SINCE THE PATIENT COULD NOT BE REACHED BY PHONE FOR FOLLOW-UP QUESTIONS. THE REPORTER ALLEGED THAT THE ISSUES OCCURRED ON (B)(6) 2025, AT AN UNSPECIFIED TIME. THE PATIENT MANAGES THEIR DIABETES WITH A COMBINATION OF MEDICATION (LANTUS INSULIN 19 UNITS AND GLIPIZIDE ¿ 1 TABLET TWICE A DAY) AND THE REPORTER DENIED THAT THE PATIENT TOOK ANY ACTION IN RESPONSE TO THE ALLEGED ISSUES. THAT SAME DAY, AT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT WAS ¿SHAKING, HAD A CONVULSION, WAS DIZZY AND DID NOT KNOW WHERE THEY WERE¿. THAT SAME DAY, AROUND 8 O¿CLOCK (AM OR PM WAS NOT SPECIFIED), THE PARAMEDICS WERE CALLED AND A BLOOD GLUCOSE READING OF ¿40 MG/DL¿ WAS OBTAINED ON AN EMERGENCY MEDICAL SERVICES (EMS) METER INDICATING THE PATIENT WAS ¿HYPOGLYCEMIC¿. THE REPORTER IS UNSURE WHETHER THE PARAMEDICS PROVIDED THE PATIENT WITH ANY T
Patient problems: Confusion/ Disorientation; Convulsion/Seizure; Dizziness; Hypoglycemia; Shaking/Tremors
MAUDE report 21704314 ↗
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.
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