BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TESTOSTERONE TEST

    MDR report key: 20182661 · Received September 9, 2024

    Report

    Report Number
    MW5159386
    Event Type
    Injury
    Date Received
    September 9, 2024
    Date of Event
    June 10, 2024
    Report Date
    September 5, 2024
    Manufacturer
    EVERLYWELL DIAGNOSTICS/ EVERLYWELL, INC.
    Product Code
    CDZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    EVERLYWELL TESTOSTERONE TEST KITS (2 PERFORMED) ARE EXTREMELY INACCURATE WHEN COMPARED TO VENOUS LAB TESTING. INITIALLY ADJUSTED EXOGENOUS HORMONE SUPPLEMENTATION BASED ON RESULTS, AT A DETRIMENT TO PERSONAL HEALTH. AFTER REALIZING LAB TESTS WERE INACCURATE, CONFIRMED TRUE LEVELS WITH MEDICAL LABORATORY VENOUS DRAW AND WAS ABLE TO AVOID PERMANENT MEDICAL ISSUES. NONE OF THE TEST KITS FROM EVERLYWELL WERE ACCURATE. REF REPORT: MW5159385.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1588638 TESTOSTERONE TEST RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE CDZ EVERLYWELL DIAGNOSTICS/ EVERLYWELL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male Required Intervention ALBUTEROL| ALLEGRA| BERBERINE| FLONASE| METFORMIN