OneTouch Verio Reflect 024-237Recalls & reported problems
LifeScan Europe GmbH · OneTouch Verio Reflect Blood Glucose Monitoring System. Value Pack Kit · Class 2
All models of OneTouch Verio Reflect (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00353885012430), received between Mar 13, 2026 and Mar 17, 2026 — classified as 4 injuries.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (4 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings4
Patient problems
- Loss of consciousness4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMar 17, 2026Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6) 2026, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA ALLEGING THAT THEIR ONETOUCH VERIO REFLECT METER WAS READING INACCURATELY ERRATIC. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL AND ADDITIONAL INFORMATION OBTAINED BY REVIEW OF THE CALL BY A MEDICAL SURVEILLANCE SPECIALIST. THE ALLEGED ISSUE BEGAN ON (B)(6) 2025. THE PATIENT REPORTED RECEIVING READINGS OF "132MG/DL" AND "167MG/DL" WITH LESS THAN 20 MINUTES BETWEEN RESULTS WITH THE SUBJECT DEVICE. THE PATIENT ALSO REPORTED RECEIVING CONSISTENTLY HIGH READINGS COMPARED TO HER FEELINGS AND DEXCOM G6 SENSOR. THE PATIENT MANAGES THEIR DIABETES USING AN INSULIN POD WHICH DELIVERS ONE-THIRD OF A UNIT OF INSULIN PER HOUR. AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT INCREASED THEIR DOSE OF MEDICATION (INCREASED DOSE UNKNOWN). AFTER 3PM ON (B)(6) 2025, THE PATIENT BECAME UNCONSCIOUS. EMERGENCY SERVICES MEASURED THE PATIENT'S BLOOD GLUCOSE USING THEIR METER WHICH REVEALED THE PATIENT'S BLOOD GLUCOSE WAS "LOW". EMERGENCY SERVICES TREATED THE PATIENT WITH IV DEXTROSE. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECT
Patient problems: Loss of consciousness
MAUDE report 24618088 ↗InjuryMar 17, 2026Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6) 2026, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA ALLEGING THAT THEIR ONETOUCH VERIO REFLECT METER WAS READING INACCURATELY ERRATIC. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL AND ADDITIONAL INFORMATION OBTAINED BY REVIEW OF THE CALL BY A MEDICAL SURVEILLANCE SPECIALIST. THE ALLEGED ISSUE BEGAN ON (B)(6) 2025. THE PATIENT REPORTED RECEIVING READINGS OF "132MG/DL" AND "167MG/DL" WITH LESS THAN 20 MINUTES BETWEEN RESULTS WITH THE SUBJECT DEVICE. THE PATIENT ALSO REPORTED RECEIVING CONSISTENTLY HIGH READINGS COMPARED TO HER FEELINGS AND DEXCOM G6 SENSOR. THE PATIENT MANAGES THEIR DIABETES USING AN INSULIN POD WHICH DELIVERS ONE-THIRD OF A UNIT OF INSULIN PER HOUR. AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT INCREASED THEIR DOSE OF MEDICATION (INCREASED DOSE UNKNOWN). AFTER 3PM ON (B)(6) 2025, THE PATIENT BECAME UNCONSCIOUS. EMERGENCY SERVICES MEASURED THE PATIENT'S BLOOD GLUCOSE USING THEIR METER WHICH REVEALED THE PATIENT'S BLOOD GLUCOSE WAS "LOW". EMERGENCY SERVICES TREATED THE PATIENT WITH IV DEXTROSE. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECT
Patient problems: Loss of consciousness
MAUDE report 24617962 ↗InjuryMar 17, 2026Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6) 2026, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THEIR ONETOUCH VERIO REFLECT METER WAS READING INACCURATELY ERRATIC. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA), DURING THE INITIAL CALL AND ADDITIONAL INFORMATION OBTAINED BY REVIEW OF THE CALL BY A MEDICAL SURVEILLANCE SPECIALIST. THE ALLEGED ISSUE BEGAN ON (B)(6) 2025. THE PATIENT REPORTED RECEIVING READINGS OF "132MG/DL" AND "167MG/DL" WITH LESS THAN 20 MINUTES BETWEEN RESULTS, WITH THE SUBJECT DEVICE. THE PATIENT ALSO REPORTED RECEIVING CONSISTENTLY HIGH READINGS COMPARED TO HER FEELINGS AND DEXCOM G6 SENSOR. THE PATIENT MANAGES THEIR DIABETES USING AN INSULIN POD WHICH DELIVERS ONE-THIRD OF A UNIT OF INSULIN PER HOUR. AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT INCREASED THEIR DOSE OF MEDICATION (INCREASED DOSE UNKNOWN). AFTER 3PM ON (B)(6) 2025, THE PATIENT BECAME UNCONSCIOUS. EMERGENCY SERVICES MEASURED THE PATIENT'S BLOOD GLUCOSE USING THEIR METER WHICH REVEALED THE PATIENT'S BLOOD GLUCOSE WAS "LOW". EMERGENCY SERVICES TREATED THE PATIENT WITH IV DEXTROSE. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORR
Patient problems: Loss of consciousness
MAUDE report 24617810 ↗InjuryMar 13, 2026Incorrect, Inadequate or Imprecise Result or Readings
ON 21 FEB 2026, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA ALLEGING THAT THEIR ONETOUCH VERIO REFLECT METER WAS READING INACCURATELY ERRATIC. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL AND ADDITIONAL INFORMATION OBTAINED BY REVIEW OF THE CALL BY A MEDICAL SURVEILLANCE SPECIALIST. THE ALLEGED ISSUE BEGAN ON 20 NOV 2025. THE PATIENT REPORTED RECEIVING READINGS OF "132MG/DL" AND "167MG/DL" WITH LESS THAN 20 MINUTES BETWEEN RESULTS WITH THE SUBJECT DEVICE. THE PATIENT ALSO REPORTED RECEIVING CONSISTENTLY HIGH READINGS COMPARED TO HER FEELINGS AND DEXCOM G6 SENSOR. THE PATIENT MANAGES THEIR DIABETES USING AN INSULIN POD WHICH DELIVERS ONE-THIRD OF A UNIT OF INSULIN PER HOUR. AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT INCREASED THEIR DOSE OF MEDICATION (INCREASED DOSE UNKNOWN). AFTER 3PM ON (B)(6) 2025, THE PATIENT BECAME UNCONSCIOUS. EMERGENCY SERVICES MEASURED THE PATIENT'S BLOOD GLUCOSE USING THEIR METER WHICH REVEALED THE PATIENT'S BLOOD GLUCOSE WAS "LOW". EMERGENCY SERVICES TREATED THE PATIENT WITH IV DEXTROSE. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECT
Patient problems: Loss of consciousness
MAUDE report 24597635 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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