OneTouch Verio Flex 024-267Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00353885012485), received between Feb 19, 2025 and Feb 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. How this data works · Data updated Oct 13, 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.

• InjuryFeb 19, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  ON (B)(6) 2025, A LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THEIR ONETOUCH VERIO FLEX METER WAS GENERATING ERROR 4 RESULTS. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL SINCE THE PATIENT COULD NOT BE REACHED TO OBTAIN ADDITIONAL INFORMATION. THE PATIENT STATED THAT THE ALLEGED ISSUE BEGAN ON THE MORNING OF (B)(6) 2024, AND THAT THEY HAD BEEN GETTING ERROR 4 MESSAGES FOR 2 WEEKS. EVER SINCE THE FIRST TIME HE USED 4 CONSECUTIVE STRIPS WHICH GENERATED ERROR 4 RESULTS, THE PATIENT HAS BEEN GETTING THE ERROR 4 MESSAGE CONSISTENTLY. SINCE (B)(6) 2024, THE PATIENT HAD FEELINGS OF ANXIETY AND ON (B)(6) 2025, THE PATIENT FELT DIZZY, NAUSEOUS AND FELL UNCONSCIOUS. IN RESPONSE TO THE ALLEGED ISSUE, THE CUSTOMER DID NOT TAKE ANY ACTION OR RECEIVE TREATMENT. THE PATIENT MANAGES THEIR DIABETES WITH GLIPIZIDE 5MG, AT BREAKFAST AND AT NIGHT. THE CCA NOTED THAT THE TEST STRIPS HAD BEEN REMOVED FROM THEIR ORIGINAL VIAL AND WERE BEING STORED A PILL CONTAINER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS THEY WERE UNABLE TO TEST THEIR BLOOD GLUCOSE DU

  Patient problems: Anxiety; Dizziness; Nausea; Syncope/Fainting

  MAUDE report 21409086 ↗
• InjuryFeb 19, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  ON (B)(6) 2025, A LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THEIR ONETOUCH VERIO FLEX METER WAS GENERATING ERROR 4 RESULTS. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL SINCE THE PATIENT COULD NOT BE REACHED TO OBTAIN ADDITIONAL INFORMATION. THE PATIENT STATED THAT THE ALLEGED ISSUE BEGAN ON THE MORNING OF (B)(6) 2024, AND THAT THEY HAD BEEN GETTING ERROR 4 MESSAGES FOR 2 WEEKS. EVER SINCE THE FIRST TIME HE USED 4 CONSECUTIVE STRIPS WHICH GENERATED ERROR 4 RESULTS, THE PATIENT HAS BEEN GETTING THE ERROR 4 MESSAGE CONSISTENTLY. SINCE (B)(6) 2024, THE PATIENT HAD FEELINGS OF ANXIETY AND ON (B)(6) 2025, THE PATIENT FELT DIZZY, NAUSEOUS AND FELL UNCONSCIOUS. IN RESPONSE TO THE ALLEGED ISSUE, THE CUSTOMER DID NOT TAKE ANY ACTION OR RECEIVE TREATMENT. THE PATIENT MANAGES THEIR DIABETES WITH GLIPIZIDE 5MG, AT BREAKFAST AND AT NIGHT. THE CCA NOTED THAT THE TEST STRIPS HAD BEEN REMOVED FROM THEIR ORIGINAL VIAL AND WERE BEING STORED A PILL CONTAINER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS THEY WERE UNABLE TO TEST THEIR BLOOD GLUCOSE DU

  Patient problems: Anxiety; Dizziness; Nausea; Syncope/Fainting

  MAUDE report 21409073 ↗