OneTouch Verio Reflect 024-369Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00353885012959), received between Jun 20, 2025 and Jun 20, 2025 — classified as 2 injuries.

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

• InjuryJun 20, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  ON (B)(6) 2025, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THEIR ONETOUCH VERIO REFLECT METER WAS DISPLAYING ERROR 2, 4 AND 6 MESSAGES. 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 BEGAN AT AN UNSPECIFIED DATE/TIME APPROXIMATELY ONE AND A HALF WEEKS BEFORE THE END OF (B)(6) 2025. THE PATIENT MANAGES THEIR DIABETES WITH SELF-ADJUSTED INSULIN (LANTUS AND HUMALOG, DOSES NOT SPECIFIED, TAKEN DAILY) AND THE ADVISED THAT IN RESPONSE TO THE ALLEGED ISSUE, THEY STOPPED ADMINISTERING THEIR MEDICATION. THE PATIENT ALLEGED THAT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE(S) BEGAN, THEY ¿FELT HIGH GLUCOSE¿, THAT THEY ¿PASSED OUT AND HAD DIABETIC KETOACIDOSIS¿. THE PATIENT ADVISED THAT THEY CONTACTED EMERGENCY MEDICAL SERVICES (EMS) WHO REPORTEDLY ATTENDED AND SUBSEQUENTLY ADMINISTERED ¿INSULIN DRIP, SODIUM, WATER AND POTASSIUM¿. THE CUSTOMER WAS UNABLE AND/OR UNWILLING TO CONFIRM IF THEIR BLOOD GLUCOSE WAS MEASURED AT THE TIME OF EMS ARRIVAL. AT THE TIME OF TROUBLESHOOTING, THE CCA ESTABLISHED THA

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia; Syncope/Fainting

  MAUDE report 22296367 ↗
• InjuryJun 20, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  ON (B)(6) 2025, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THEIR ONETOUCH VERIO REFLECT METER WAS DISPLAYING ERROR 2, 4 AND 6 MESSAGES. 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 BEGAN AT AN UNSPECIFIED DATE/TIME APPROXIMATELY ONE AND A HALF WEEKS BEFORE THE END OF (B)(6) 2025. THE PATIENT MANAGES THEIR DIABETES WITH SELF-ADJUSTED INSULIN (LANTUS AND HUMALOG, DOSES NOT SPECIFIED, TAKEN DAILY) AND THE ADVISED THAT IN RESPONSE TO THE ALLEGED ISSUE, THEY STOPPED ADMINISTERING THEIR MEDICATION. THE PATIENT ALLEGED THAT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE(S) BEGAN, THEY ¿FELT HIGH GLUCOSE¿, THAT THEY ¿PASSED OUT AND HAD DIABETIC KETOACIDOSIS¿. THE PATIENT ADVISED THAT THEY CONTACTED EMERGENCY MEDICAL SERVICES (EMS) WHO REPORTEDLY ATTENDED AND SUBSEQUENTLY ADMINISTERED ¿INSULIN DRIP, SODIUM, WATER AND POTASSIUM¿. THE CUSTOMER WAS UNABLE AND/OR UNWILLING TO CONFIRM IF THEIR BLOOD GLUCOSE WAS MEASURED AT THE TIME OF EMS ARRIVAL. AT THE TIME OF TROUBLESHOOTING, THE CCA ESTABLISHED THA

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia; Syncope/Fainting

  MAUDE report 22296269 ↗