BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVONGO BLOOD GLUCOSE METER

    MDR report key: 8678943 · Received June 6, 2019

    Report

    Report Number
    MW5087182
    Event Type
    Malfunction
    Date Received
    June 6, 2019
    Date of Event
    June 4, 2019
    Report Date
    June 4, 2019
    Manufacturer
    LIVONGO HEALTH
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    TODAY I CONFIRMED WITH MY ENDOCRINOLOGIST THAT MY LIVONGO BLOOD GLUCOSE METER IS PRODUCING RESULTS THAT ARE BIASED, EXCESSIVELY VARIABLE, AND INCONSISTENT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467691 LIVONGO BLOOD GLUCOSE METER SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW LIVONGO HEALTH BG300

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR