BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVONGO BLOOD PRESSURE MONITOR

    MDR report key: 16546743 · Received March 15, 2023

    Report

    Report Number
    3011196194-2023-00021
    Event Type
    Injury
    Date Received
    March 15, 2023
    Date of Event
    March 1, 2023
    Report Date
    March 10, 2023
    Manufacturer
    LIVONGO HEALTH, INC.
    Product Code
    DXN
    PMA / PMN Number
    K131395
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT WAS EDUCATED ON HOW TESTING WITH A CUFF THAT IS TOO SMALL CAN CAUSE HIGH INACCURATE READINGS. ONCE THE NEW LIVONGO MONITOR HAS BEEN RELEASED WITH A LARGER CUFF THE MEMBER WILL BE SENT A REPLACEMENT AS A RESOLUTION. IN THE MEANTIME THE PATIENT WILL STOP TESTING WITH THE LIVONGO MONITOR.

    Description of Event or Problem · 0

    THE PATIENT STATED THAT THEY TOOK THEIR LIVONGO BLOOD PRESSURE MONITOR TO THEIR DOCTOR'S OFFICE TO COMPARE AGAINST A MANUAL CUFF READING, AND RECEIVED A 50 POINT DIFFERENCE IN READINGS. THE LIVONGO BLOOD PRESSURE MONITOR READ 174/97 AND THE MANUAL CUFF READ 124/80. THE PATIENT DISCLOSED THAT THEIR DOCTOR WAS PREVIOUSLY PRESCRIBING THEIR MEDICATION BASED ON THE READINGS THAT WERE SENT OVER FROM THE LIVONGO BLOOD PRESSURE MONITOR. AFTER THEY COMPARED THE LIVONGO MONITOR TO A MANUAL CUFF IT WAS DETERMINED THAT THE LIVONGO CUFF WAS TOO SMALL FOR THE MEMBER'S ARM CAUSING HIGHER READINGS. THE PATIENTS MEDICATION WAS READJUSTED TO THE APPROPRIATE PRESCRIPTION BASED ON THE MANUAL READINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914285 LIVONGO BLOOD PRESSURE MONITOR BLOOD PRESSURE MONITOR DXN LIVONGO HEALTH, INC. HT900

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Other