BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVONGO BLOOD PRESSURE MONITOR

    MDR report key: 10523599 · Received September 11, 2020

    Report

    Report Number
    3011196194-2020-00036
    Event Type
    Malfunction
    Date Received
    September 11, 2020
    Date of Event
    August 11, 2020
    Report Date
    September 11, 2020
    Manufacturer
    LIVONGO HEALTH INC
    Product Code
    DXN
    PMA / PMN Number
    K170196
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIVONGO BLOOD PRESSURE MONITOR HAVE NOT BEEN RETURNED TO 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 THAT THE BATTERIES INSIDE OF THEIR HYPERTENSION MONITOR LEAKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986638 LIVONGO BLOOD PRESSURE MONITOR BLOOD PRESSURE MONITOR DXN LIVONGO HEALTH INC UA-651-BLE

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR