BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVONGO BLOOD PRESSURE MONITOR

    MDR report key: 18941186 · Received March 20, 2024

    Report

    Report Number
    3011196194-2024-00016
    Event Type
    Injury
    Date Received
    March 20, 2024
    Date of Event
    February 20, 2024
    Report Date
    May 6, 2024
    Manufacturer
    TELADOC HEALTH, INC
    Product Code
    DXN
    PMA / PMN Number
    K202891
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE ASSOCIATED WITH THIS INCIDENT WAS RETURNED FOR INVESTIGATION/EVALUATION. A RETURN DEVICES INVESTIGATION WAS PERFORMED, BUT THE DEVICE FAILED INVESTIGATION TESTING. IT WAS FOUND THAT THE DEVICE WAS NOT ACCURATE IN THE HYPERTENSIVE RANGE OF 150/100. THE ISSUE CAN BE ATTRIBUTED TO A MANUFACTURING DEFICIENCY.

    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 PATIENT STATED THAT THE CUFF CONTINUED TO INFLATE, WENT OVER 200, GOT TIGHT, AND CAUSED BRUISING. THE PATIENT SAID SHE CANCELED THE READING TO STOP THE MONITOR BUT SAID THE CUFF DID NOT FULLY DEFLATE. THE PATIENT DID NOT SEEK MEDICAL ATTENTION. IT WAS DETERMINED THAT THE CUFF WAS THE CORRECT SIZE FOR THE PATIENT.

    Description of Event or Problem · 0

    THE PATIENT STATED THAT THE CUFF CONTINUED TO INFLATE, WENT OVER 200, GOT TIGHT, AND CAUSED BRUISING. THE PATIENT SAID SHE CANCELED THE READING TO STOP THE MONITOR BUT SAID THE CUFF DID NOT FULLY DEFLATE. THE PATIENT DID NOT SEEK MEDICAL ATTENTION. IT WAS DETERMINED THAT THE CUFF WAS THE CORRECT SIZE FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487795 LIVONGO BLOOD PRESSURE MONITOR BLOOD PRESSURE MONITOR DXN TELADOC HEALTH, INC HT945

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Unknown Other