BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART WATCH ET 428

    MDR report key: 20203144 · Received September 11, 2024

    Report

    Report Number
    MW5159548
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Date of Event
    July 30, 2024
    Manufacturer
    UNK
    Product Code
    QDA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IS
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE DATA OBTAINED FROM THE BLOOD GLUCOSE TEST ARE EXTREMELY LOW COMPARED TO OTHER TEST, LIKE THE MEASUREMENT OF A DROP OF BLOOD WITH THE ACCU CHECK DEVICE. THE MEASUREMENTS ARE UP TO 50% LOWER, WHICH CAN LEAD TO ERRORS IN THE ASSESSMENT OF THE PROBLEM AND ITS TREATMENT. THIS IS RELATED TO A SMART WATCH THAT I BOUGHT THROUGH THE DIGITAL STORE ALI EXPRESS, THE ADVERTISEMENT IS ATTACHED HERE. THIS DEVICE OFFERS OTHER ANALYSES, SUCH AS BLOOD BIOCHEMISTRY, WHICH ARE ALSO QUITE LOW COMPARED TO OTHER TESTS DONE IN A LABORATORY. OTHER MEASUREMENTS, SUCH AS HEART RATE AND BLOOD PRESSURE, SEEM CORRECT. I SUGGEST AN EXPEDITED COMPLAINT AGAINST THE ALI EXPRESS STORE, WHICH SURELY YOU KNOW WHO THE MANUFACTURERS OF THE DEVICE ARE. "LIFE STYLE". HOWEVER, THESE LABORATORY TESTS ARE NOT RECENT, BUT COMPARING THEM OVER PAST TIME, THESE ARE THE USUAL (COMMON) RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506408 SMART WATCH ET 428 ELECTROCARDIOGRAPH SOFTWARE FOR OVER-THE-COUNTER USE QDA UNK ET 428

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other BEZAFIBRATE 400 MG| DUODART 0.5 MG| ELTROXIN 5 MG| EZETROL 10 MG| JARDIANCE 25 MG| LITORVA 40 MG| TRAJENTA DUE 2.5/850 MG| VINIA | VITAMIN B12