BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELADOC BLOOD PRESSURE MONITOR

    MDR report key: 25161039 · Received May 13, 2026

    Report

    Report Number
    3011196194-2026-00037
    Event Type
    Malfunction
    Date Received
    May 13, 2026
    Date of Event
    May 1, 2026
    Report Date
    May 12, 2026
    Manufacturer
    TELADOC HEALTH, INC.
    Product Code
    DXN
    PMA / PMN Number
    K202891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A REPLACEMENT MONITOR WAS NOT SENT TO THE PATIENT DUE TO THEIR REQUEST TO CANCEL THE ACCOUNT. THE DEVICE ASSOCIATED WITH THIS INCIDENT WAS NOT RETURNED FOR INVESTIGATION. IF THE DEVICE IS RETURNED, AN INVESTIGATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    DURING A VISIT TO THEIR CARDIOLOGIST'S OFFICE, THE PATIENT REPORTED THAT UNDER IDENTICAL CONDITIONS AND POSITIONING, THE TELADOC BLOOD PRESSURE MONITOR RECORDED HIGHER READINGS THAN THE DOCTOR'S MANUAL BLOOD PRESSURE MONITOR. THE TELADOC READING WAS 180/116, WHILE THE DOCTOR'S READING WAS 150/90, TAKEN ONE MINUTE APART ON THE SAME ARM AND IN THE SAME POSITION. THIS REFLECTS A DIFFERENCE GREATER THAN 20 MMHG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236347 TELADOC BLOOD PRESSURE MONITOR BLOOD PRESSURE MONITOR DXN TELADOC HEALTH, INC. HT945

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Unknown