BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERKINELMER COVID-19 ANTIGEN TEST

    MDR report key: 11371975 · Received February 23, 2021

    Report

    Report Number
    MW5099556
    Event Type
    Malfunction
    Date Received
    February 23, 2021
    Date of Event
    February 1, 2021
    Report Date
    February 21, 2021
    Manufacturer
    PERKINELMER, INC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MENTAL DISTRESS; I HAD A POSITIVE COVID TEST COME BACK ON (B)(6) 2021 AND 2 DAYS LATER HAD ANOTHER TEST COME BACK NEGATIVE ON (B)(6) 2021. I FEEL LIKE THE TEST IS FAULTY AT (B)(6) HOSPITAL WHERE I RECEIVED MY FIRST TEST. SECOND TEST WAS DONE AT (B)(6) URGENT CLINIC. I WAS NEVER SICK AND I HAD BEEN AROUND MY GRANDMOTHER'S HELPING THEM AND THEY TESTED NEGATIVE. I LIVE ALONE AND RARELY GO OUT. I DOUBLE MASK AND I'M VERY CAREFUL. THIS FALSE RESULT HAD MY 5 MENTAL ILLNESSES GO CRAZY FOR THE FIRST 2 DAYS FEELING AFRAID OF MYSELF. I THOUGHT I WAS MAKING MYSELF SICK. I NEVER FELT SICK NOR WAS I. I DON'T TRUST (B)(6) HOSPITALS TESTS ANYMORE. (B)(6) URGENT CARE IS MORE RELIABLE. I WAS TOLD BY (B)(6) COMMUNICABLE DISEASES INVESTIGATOR THAT THEY CAN'T DO ANYTHING ABOUT IT. I HAD TO HAVE BEEN SICK AND ON MY LAST 2 DAYS OF MY SICKNESS. I TEST OFTEN AND THEY ARE WRONG FOR PUTTING ME IN THIS CATEGORY WHEN I NEVER HAD THE SICKNESS. IT WAS THERE FALSE TESTING. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266701 PERKINELMER COVID-19 ANTIGEN TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP PERKINELMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other