BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELADOC BLOOD PRESSURE MONITOR

    MDR report key: 25135660 · Received May 11, 2026

    Report

    Report Number
    3011196194-2026-00032
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 5, 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

    THE DEVICE RELATED TO THIS INCIDENT WAS RETURNED FOR INVESTIGATION. INTERNAL FUNCTIONAL TESTING WAS PERFORMED, AND NO FAILURES WERE DETECTED DURING FUNCTIONAL TESTING. THE INTERNAL INVESTIGATION CONFIRMED THE DEVICE WAS WORKING AS INTENDED.

    Description of Event or Problem · 0

    THE MEMBER REPORTED AN ACCURACY CONCERN WITH THEIR TELADOC HEALTH BLOOD PRESSURE MONITOR. THE MEMBER REPORTED THAT THEY WERE EXPERIENCING ISSUES REGARDING COMPARING MONITORS. MEMBER SUPPORT EDUCATED THE MEMBER ON PROPER TECHNIQUE AND USAGE AND ELIMINATED EXTERNAL FACTORS. THE MEMBER COMPARED THEIR TELADOC BLOOD PRESSURE MONITOR READING WITH A MANUAL READING TAKEN AT THEIR DOCTOR'S OFFICE. BOTH READINGS WERE COMPLETED BACK-TO-BACK OR WITHIN MINUTES OF EACH OTHER. THE MANUAL READING WAS 130/103, WHILE THE TELADOC MONITOR DISPLAYED 170/103 AND 192/103, REFLECTING A VARIANCE GREATER THAN 20 MMHG. MEMBER SUPPORT PLACED AN ORDER FOR A REPLACEMENT DEVICE AND THE MEMBER SENT BACK THE ORIGINAL DEVICE FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510653 TELADOC BLOOD PRESSURE MONITOR BLOOD PRESSURE MONITOR DXN TELADOC HEALTH, INC. HT945

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Unknown