BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVONGO BLOOD PRESSURE MONITOR

    MDR report key: 17470778 · Received August 7, 2023

    Report

    Report Number
    3011196194-2023-00072
    Event Type
    Malfunction
    Date Received
    August 7, 2023
    Date of Event
    June 11, 2023
    Report Date
    August 6, 2023
    Manufacturer
    TELADOC HEALTH, INC.
    Product Code
    DXN
    PMA / PMN Number
    K131395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE ASSOCIATED WITH THIS INCIDENT WAS NOT RETURNED FOR INVESTIGATION. SHOULD THIS DEVICE BE RETURNED, A SUPPLEMENTAL REPORT WILL BE FILED TO DOCUMENT THE RESULTS OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THE MEMBER REPORTED THAT THEIR BLOOD PRESSURE MONITOR IS INACCURATE, AND THE CUFF CAUSED BRUISING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1323100 LIVONGO BLOOD PRESSURE MONITOR BLOOD PRESSURE MONITOR DXN TELADOC HEALTH, INC. HT900

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Unknown