BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVID TEST

    MDR report key: 20504534 · Received October 21, 2024

    Report

    Report Number
    MW5161255
    Event Type
    Injury
    Date Received
    October 21, 2024
    Date of Event
    October 13, 2024
    Report Date
    October 14, 2024
    Manufacturer
    ACON LABORATORIES, INC.
    Product Code
    QKP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I NOTICED THE LIQUID WAS DISCOLORED AND SMALLER AMOUNT THAN USUAL SO IT WAS CONCERNING. ALSO EVERY TIME I TAKE THIS TEST MY SYMPTOMS ARE FAR WORSE THAN THE LAST! IT'S LIKE IT'S MAKING COVID STRONGER IN MY BODY OR SOMETHING. WHEN I DON'T TAKE THE TEST MY SYMPTOMS ARE MILD AND GO AWAY QUICKLY LIKE A COMMON COLD. SOMETHING IS OFF ABOUT THIS TEST. MAYBE THERE IS SOMETHING IN THAT COTTON SWAB THAT AS SOON AS YOU ENTER IT INTO YOUR NOSE THERE'S A BAD DRUG INTERACTION OR SOMETHING. PLEASE MAKE THE PUBLIC AWARE AGAIN. I HAD NO IDEA THERE WAS A RECALL OR AN EXPIRATION DATE FOR THESE TEST. I AM NOT WELL AND I KNOW IT'S BECAUSE OF THIS TEST KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1925022 COVID TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACON LABORATORIES, INC. (17)231122 (10)COV2020165

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Disability| O AMLODIPINE 10 MG