BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART WATCH OLEVX

    MDR report key: 20212530 · Received September 12, 2024

    Report

    Report Number
    MW5159584
    Event Type
    Injury
    Date Received
    September 12, 2024
    Date of Event
    August 15, 2024
    Manufacturer
    UNK
    Product Code
    QDA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I BOUGHT AN OLEVS SMARTWATCH TO HELP MONITOR MY TYPE 2 DIABETES. THE READINGS WERE WAY OUT. FOR EXAMPLE THE WATCH READ 5.9 AND MY GLUCOSE METER WAS 11.2. NOW I AM HAVING TROUBLE RETURNING THIS USELESS DEVICE AND GETTING A (B)(6) REFUND. I TESTED THIS WATCH AGAINST BY GLUCOSE METER FOR 36 HOURS WITH TOTALLY INACCURATE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1113390 SMART WATCH OLEVX ELECTROCARDIOGRAPH SOFTWARE FOR OVER-THE-COUNTER USE QDA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Life Threatening AMLODIPINE| ANTI CHOLESTEROL | INSULIN | METFORMIN | MUTI VITAMIN| URIC ACID