BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVONGO BLOOD GLUCOSE METER

    MDR report key: 10794504 · Received November 5, 2020

    Report

    Report Number
    3011196194-2020-00040
    Event Type
    Injury
    Date Received
    November 5, 2020
    Date of Event
    October 8, 2020
    Report Date
    November 5, 2020
    Manufacturer
    LIVONGO 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 · 1

    NEITHER THE BLOOD GLUCOSE METER, NOR THE TEST STRIPS WERE RETURNED TO THE MANUFACTURER. TROUBLESHOOTING STEPS ARE STILL ONGOING WITH THE PATIENT. AN INVESTIGATION WILL BE PERFORMED, BUT HAS NOT YET BEGUN. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT REPORTED RECEIVING LOW GLUCOSE READINGS WHILE USING THEIR LIVONGO BLOOD GLUCOSE METER. HOWEVER, WHEN PARAMEDICS TOOK THE PATIENT TO THE HOSPITAL, THE PATIENT WAS TREATED WITH INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254605 LIVONGO BLOOD GLUCOSE METER BLOOD GLUCOSE METER NBW LIVONGO HEALTH INC BG300C N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention