BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDICAID COVID-19 ANTIGEN RAPID TEST

    MDR report key: 22803859 · Received August 14, 2025

    Report

    Report Number
    MW5174499
    Event Type
    Malfunction
    Date Received
    August 14, 2025
    Date of Event
    August 9, 2025
    Report Date
    August 10, 2025
    Manufacturer
    PHASE SCIENTIFIC INTERNATIONAL LIMITED
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THERE IS SOMETHING NOT RIGHT ABOUT THESE TESTS. I THINK THEY ARE FRAUDULENT COVID TESTS. PLEASE INVESTIGATE! HTTPS://A.CO/D/60QIYVK INDICAID COVID-19 ANTIGEN RAPID TEST, 6 TESTS IN 3 INDIVIDUAL PACKS, FDA EUA AUTHORIZED OTC COVID HOME TEST, HSA/FSA ELIGIBLE, FAST AND EASY TO USE. WHEN I SWAB MY NOSE IT TESTS POSITIVE FOR COVID EVEN THOUGH FDA CLEARED COVID TESTS ARE NEGATIVE. I THINK IT'S A SOPHISTICATED FRAUDULENT TEST THAT DETECTS LIKE NOSE CELLS OR MUCUS OR SOMETHING BUT NOT REALLY COVID. IT'S MISLEADING AND COULD CAUSE A LOT OF HARM! IT MADE ME MISS OUT ON SOME IMPORTANT EVENTS AND ALSO WORK! PATIENT CODE: 4581. DEVICE CODES: 1535, 1506. REFERENCE REPORTS: MW5174500, MW5174501.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180662 INDICAID COVID-19 ANTIGEN RAPID TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP PHASE SCIENTIFIC INTERNATIONAL LIMITED ZZ0046CE 24100004

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female