BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELADOC BLOOD GLUCOSE METER

    MDR report key: 23316746 · Received October 16, 2025

    Report

    Report Number
    3011196194-2025-00095
    Event Type
    Injury
    Date Received
    October 16, 2025
    Date of Event
    September 25, 2025
    Report Date
    October 10, 2025
    Manufacturer
    TELADOC HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K133584
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT WAS SENT A REPLACEMENT DEVICE TO RESOLVE THIS ISSUE. THE DEVICE ASSOCIATED WITH THIS INCIDENT WAS RETURNED FOR INVESTIGATION. INITAL FUNCTIONAL TESTING WAS PERFORMED AND NO DAMAGES OR NONCONFORMENCES WERE FOUND. CONTROL SOLUTION TESTS WERE PERFORMED ON THE DEVICE AND THE RESULTS WERE IN RANGE.

    Description of Event or Problem · 0

    THE PATIENT REPORTED CONCERNS ABOUT THE ACCURACY OF THEIR TELADOC HEALTH BLOOD GLUCOSE METER. THE READINGS FROM THE TELADOC METER WERE CONSISTENTLY LOWER COMPARED TO THOSE OBTAINED AT THE DOCTOR'S OFFICE. BASED ON THESE INCORRECT READINGS, THE PATIENT'S DOCTOR ADJUSTED THEIR MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2694855 TELADOC BLOOD GLUCOSE METER BLOOD GLUCOSE METER NBW TELADOC HEALTH, INC. BG300C

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Unknown Other