BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVONGO BLOOD GLUCOSE METER

    MDR report key: 19750743 · Received July 16, 2024

    Report

    Report Number
    3011196194-2024-00034
    Event Type
    Injury
    Date Received
    July 16, 2024
    Date of Event
    June 18, 2024
    Report Date
    July 15, 2024
    Manufacturer
    TELADOC HEALTH INC
    Product Code
    NBW
    PMA / PMN Number
    K133584
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR THE INVESTIGATION. IT WAS FOUND THAT THE PATIENT WAS USING EXPIRED TEST STRIPS, AND THE PATIENT WAS SENT NEW TEST STRIPS TO HELP RESOLVE THE ISSUE.

    Description of Event or Problem · 0

    THE PATIENT WAS RECEIVING LOW READINGS IN THE 30'S FROM THEIR LIVONGO BLOOD GLUCOSE METER. THE PATIENT WAS TAKEN OFF THEIR METFORMIN MEDICATION BY THEIR DOCTOR BASED ON THE LOW READINGS THEY WERE GETTING FROM THE LIVONGO METER. IT WAS LATER CONFIRMED THAT THE PATIENT HAS BEEN TESTING WITH EXPIRED TEST STRIPS, AND THE LOW READINGS MAY HAVE BEEN INACCURATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2505020 LIVONGO BLOOD GLUCOSE METER BLOOD GLUCOSE METER NBW TELADOC HEALTH INC BG300C

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Unknown Other