BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVONGO BLOOD PRESSURE MONITOR

    MDR report key: 16438943 · Received February 24, 2023

    Report

    Report Number
    3011196194-2023-00015
    Event Type
    Injury
    Date Received
    February 24, 2023
    Date of Event
    February 4, 2023
    Report Date
    February 23, 2023
    Manufacturer
    LIVONGO HEALTH, INC.
    Product Code
    DXN
    PMA / PMN Number
    K131395
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE BLOOD PRESSURE MONITOR WAS REQUESTED BACK FROM THE PATIENT BUT HAS NOT YET BEEN DELIVERED TO THE MANUFACTURER. WHEN THE DEVICE IS DELIVERED AN INVESTIGATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT WILL BE FILED. THIS REPORT IS BEING FILED DUE TO THE PATIENT REPORTING PAIN IN THEIR ARM FROM THE LIVONGO BLOOD PRESSURE MONITOR CUFF.

    Description of Event or Problem · 0

    PATIENT REPORTED PAIN IN THEIR LEFT ARM WHEN THEY WOULD USE THE LIVONGO BLOOD PRESSURE MONITOR. PATIENT STATED THERE IS A VISIBLE MARK ON THE ARM THAT GETS BETTER WHEN THEY STOP TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2058464 LIVONGO BLOOD PRESSURE MONITOR BLOOD PRESSURE MONITOR DXN LIVONGO HEALTH, INC. HT900

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Other