BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVONGO BLOOD GLUCOSE METER

    MDR report key: 12701097 · Received October 26, 2021

    Report

    Report Number
    3011196194-2021-00018
    Event Type
    Injury
    Date Received
    October 26, 2021
    Date of Event
    October 1, 2021
    Report Date
    October 18, 2021
    Manufacturer
    LIVONGO HEALTH INC
    Product Code
    NBW
    PMA / PMN Number
    K133584
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT REPORTED BEING ADMITTED TO THE ER DUE TO LIVONGO'S METER READINGS WERE INACCURATE. MULTIPLE ATTEMPTS TO REACH THE MEMBER FOR FURTHER INFORMATION WERE UNSUCCESSFUL. THE BG METER HAS NOT BEEN RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 0

    THE MEMBER WAS ADMITTED TO THE ER DUE TO A AN INACCURATE READING FROM THE LIVONGO'S METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1597504 LIVONGO BLOOD GLUCOSE METER BLOOD GLUCOSE METER NBW LIVONGO HEALTH INC BG300C

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization