BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD PRESSURE MONITOR CONNECT

    MDR report key: 15825688 · Received November 17, 2022

    Report

    Report Number
    MW5113359
    Event Type
    Malfunction
    Date Received
    November 17, 2022
    Date of Event
    October 31, 2022
    Report Date
    November 16, 2022
    Manufacturer
    WITHINGS S.A.
    Product Code
    DXN
    UDI-DI
    03700546705984
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I PURCHASED THE WITHINGS BPM (BLOOD PRESSURE MONITOR) CONNECT BLOOD PRESSURE MONITOR ON (B)(6) 2022. IT READ THAT I HAD HIGH BLOOD PRESSURE FAIRLY CONSISTENTLY. I SAW MY DOCTOR ON (B)(6) 2022. I BROUGHT THE DEVICE. THEY CONFIRMED THAT I DID NOT HAVE BLOOD HIGH BLOOD PRESSURE. AFTER TAKING MULTIPLE READINGS WITH THE DEVICE AND WITH THE DOCTORS OFFICE EQUIPMENT THE DEVICE WAS CONSISTENTLY AROUND 30 POINT HIGH ON SYSTOLIC. I ENGAGED WITHINGS SUPPORT. THEY HAVE BEEN UNHELPFUL, REQUESTING THAT I FOLLOW DIRECTIONS, DOUBLE CHECK MY ARM CIRCUMFERENCE IS IN THE RANGE, GET READINGS FROM OTHER PEOPLE (WHICH ALSO SEEMED INACCURATE BUT WE HAD NO DEVICE TO COMPARE TO), AND IS NOW ASKING FOR VIDEOS OF ME TAKING THE BLOOD PRESSURE. THE DEVICE IS INACCURATE. LOOKING AT ONLINE REVIEWS THIS SEEMS TO BE A PROBLEM FOR AROUND 10% OF REVIEWERS. THIS CAUSES A BURDEN ON CONSUMERS TO SEE THEIR DOCTOR WHEN UNNECESSARY OR EVEN POSSIBLY CAUSING OVER MEDICATION IF THEY ARE TRYING TO MONITOR A KNOWN PROBLEM. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1602387 BLOOD PRESSURE MONITOR CONNECT SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE DXN WITHINGS S.A. WPM05-ALL-INTER 03700546705984

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Other ASPIRIN, FISH OIL, MULTVITAMIN.| ATORVASTATIN.