BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVONGO BLOOD PRESSURE MONITOR

    MDR report key: 11832084 · Received May 17, 2021

    Report

    Report Number
    3011196194-2021-00009
    Event Type
    Malfunction
    Date Received
    May 17, 2021
    Date of Event
    March 14, 2021
    Report Date
    May 6, 2021
    Manufacturer
    LIVONGO HEALTH INC
    Product Code
    DXN
    PMA / PMN Number
    K131395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HYPERTENSION MONITOR HAS NOT BEEN RETURNED TO THE MANUFACTURER. 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 THAT SHE HAD RECEIVED INACCURATE READINGS FROM HER HYPERTENSION DEVICE. SHE HAD GONE TO THE EMERGENCY ROOM WHICH FOUND THAT HER HYPERTENSION MONITOR WAS READING HIGH BUT HER BLOOD PRESSURE WAS ACTUALLY LOW DUE TO HER MEDICATION BEING ADJUSTED INCORRECTLY BECAUSE OF THE READINGS ON HER HYPERTENSION DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735544 LIVONGO BLOOD PRESSURE MONITOR BLOOD PRESSURE MONITOR DXN LIVONGO HEALTH INC HT900

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR