BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVONGO BLOOD GLUCOSE METER

    MDR report key: 19703182 · Received July 9, 2024

    Report

    Report Number
    3011196194-2024-00031
    Event Type
    Injury
    Date Received
    July 9, 2024
    Date of Event
    June 10, 2024
    Report Date
    July 8, 2024
    Manufacturer
    TELADOC HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K133584
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT WAS SENT A REPLACEMENT DEVICE, AND THE DEVICE ASSOCIATED WITH THIS FILING WAS REQUESTED BACK FOR FUNCTIONAL TESTING. THE DEVICE HAS NOT YET BEEN RETURNED. SHOULD THE DEVICE BE RETURNED AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE PATIENT ADVISED THAT THEIR LIVONGO BLOOD GLUCOSE METER WAS PROVIDING READINGS RANGING CFROM 150-170, WHILE THEY WERE EXPERIENCING SYMPTOMS OF VOMITING AND HIGH BLOOD SUGAR. THE PATIENT SOUGHT MEDICAL ATTENTION AT AN EMERGENCY ROOM, AND RECEIVED A READING OF 550 FROM THE HOSPITAL, COMPARED TO A READING OF 150 FROM THE LIVONGO METER TAKEN AN HOUR APART. THE PATIENT WAS ADMITTED INTO THE ICU AND SPENT A WEEK IN THE HOSPITAL. THE PATIENT CONFIRMED WHILE THEY WERE JN THE ICU THEY WERE PUT ON AN INSULIN DRIP, BICARBONATE DRIP AND 3 DIFFERENT ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1268430 LIVONGO BLOOD GLUCOSE METER BLOOD GLUCOSE METER NBW TELADOC HEALTH, INC. BG300C

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Unknown Hospitalization