OneTouch Verio Reflect 023-899Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00353885011716), received between Jun 18, 2025 and Jun 19, 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 19, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  ON (B)(6) 2025, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THEIR ONETOUCH VERIO REFLECT METER WAS DISPLAYING AN ¿ERROR 2¿ (WITH SUB-ERROR CODE 2) MESSAGE DURING TESTING. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ERROR MESSAGE BEGAN TO APPEAR ON (B)(6) 2025, AND THEY WERE UNABLE TO MEASURE THEIR BLOOD GLUCOSE LEVELS. THEY DID NOT TAKE ANY ACTION REGARDING THEIR USUAL DIABETES MANAGEMENT AS A RESULT OF THE ALLEGED ISSUE. ON (B)(6), 2025, AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT CLAIMED THEY DEVELOPED SYMPTOMS OF FEELING ¿VERY WEAK AND ALMOST LOSING CONSCIOUSNESS¿. EMERGENCY MEDICAL SERVICES WERE CONTACTED FOR ASSISTANCE. WHEN THE PARAMEDICS ARRIVED, THEY FOUND THE PATIENT¿S BLOOD GLUCOSE LEVELS WERE ¿VERY LOW¿ (EXACT READING NOT PROVIDED). THE PATIENT STATED THAT THEY WERE TAKEN TO HOSPITAL WHEY THERE RECEIVED TREATMENT OF A DEXTROSE TABLET AND UNSPECIFIED MEDICATION. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME. THE CCA WALKED THE PATIENT THOUGH A TEST HOWEVER THE ALLEGED ISSUE COULD NOT BE RESOLVED. REPLACEMEN

  Patient problems: Hypoglycemia; Presyncope

  MAUDE report 22290540 ↗
• InjuryJun 18, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  ON (B)(6) 2025, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THEIR ONETOUCH VERIO REFLECT METER WAS DISPLAYING AN ¿ERROR 2¿ (WITH SUB-ERROR CODE 2) MESSAGE DURING TESTING. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ERROR MESSAGE BEGAN TO APPEAR ON (B)(6) 2025, AND THEY WERE UNABLE TO MEASURE THEIR BLOOD GLUCOSE LEVELS. THEY DID NOT TAKE ANY ACTION REGARDING THEIR USUAL DIABETES MANAGEMENT AS A RESULT OF THE ALLEGED ISSUE. ON (B)(6) 2025, AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT CLAIMED THEY DEVELOPED SYMPTOMS OF FEELING ¿VERY WEAK AND ALMOST LOSING CONSCIOUSNESS¿. EMERGENCY MEDICAL SERVICES WERE CONTACTED FOR ASSISTANCE. WHEN THE PARAMEDICS ARRIVED, THEY FOUND THE PATIENT¿S BLOOD GLUCOSE LEVELS WERE ¿VERY LOW¿ (EXACT READING NOT PROVIDED). THE PATIENT STATED THAT THEY WERE TAKEN TO HOSPITAL WHEY THERE RECEIVED TREATMENT OF A DEXTROSE TABLET AND UNSPECIFIED MEDICATION. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME. THE CCA WALKED THE PATIENT THOUGH A TEST HOWEVER THE ALLEGED ISSUE COULD NOT BE RESOLVED. REPLACEMENT

  Patient problems: Hypoglycemia; Presyncope

  MAUDE report 22288608 ↗