BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVONGO BLOOD GLUCOSE METER

    MDR report key: 10363925 · Received August 4, 2020

    Report

    Report Number
    3011196194-2020-00030
    Event Type
    Malfunction
    Date Received
    August 4, 2020
    Date of Event
    February 1, 2020
    Report Date
    July 30, 2020
    Manufacturer
    LIVONGO HEALTH INC.
    Product Code
    NBW
    PMA / PMN Number
    K133584
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE BLOOD GLUCOSE METER NOR THE TEST STRIPS HAVE BEEN RETURNED TO THE MANUFACTURER. THE DEVICE HAS YET TO BE RECEIVED BY THE MANUFACTURER, SHOULD THE DEVICE BE RETURNED, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE RESULTS OF THE TESTING.

    Description of Event or Problem · 1

    THE PATIENT REPORTED A COMPLAINT THAT THEIR LIVONGO METER WAS NOT ACCURATE. THE PATIENT RECEIVED A BLOOD GLUCOSE READING OF 60 WHEN USING HIS LIVONGO METER BUT HIS ACTUAL BLOOD GLUCOSE WAS IN THE TEENS AND THIS RESULTED IN THE PATIENT GOING INTO A DIABETIC COMA. THE PATIENT RECEIVED MEDICAL ATTENTION, WAS ADMITTED TO THE HOSPITAL, AND TREATED FOR THE DIABETIC COMA. THE PATIENT WAS SENT A REPLACEMENT BLOOD GLUCOSE METER AND TEST STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827678 LIVONGO BLOOD GLUCOSE METER BLOOD GLUCOSE METER NBW LIVONGO HEALTH INC. BG300C

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization