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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 4 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520264
Last 36 months. The most recent month may be incomplete.

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

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