BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELADOC BLOOD GLUCOSE METER

    MDR report key: 22927235 · Received August 29, 2025

    Report

    Report Number
    3011196194-2025-00083
    Event Type
    Malfunction
    Date Received
    August 29, 2025
    Date of Event
    July 31, 2025
    Report Date
    August 26, 2025
    Manufacturer
    TELADOC HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K133584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OUT OF RANGE RESULTS WERE REPORTED FROM THE TELADOC BLOOD GLUCOSE METER. IF THE DEVICE IS RETURNED, AN INVESTIGATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    CONTROL SOLUTION TESTS WERE PERFORMED ON THE TELADOC BLOOD GLUCOSE METER TO VERIFY THE DEVICE'S ACCURACY. THE RESULTS FOR CONTROL 1 AND CONTROL 2 WERE OUTSIDE THE MANUFACTURER'S ACCEPTABLE RANGE USING TWO DIFFERENT VIALS OF TEST STRIPS FROM THE SAME LOT. THE PATIENT DID NOT SEEK OR RECEIVED MEDICAL ATTENTION AS PART OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2864604 TELADOC BLOOD GLUCOSE METER BLOOD GLUCOSE METER NBW TELADOC HEALTH, INC. BG300C

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Unknown