BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVID TEST

    MDR report key: 12553901 · Received September 29, 2021

    Report

    Report Number
    MW5104284
    Event Type
    Malfunction
    Date Received
    September 29, 2021
    Report Date
    September 27, 2021
    Manufacturer
    PERKINELMER
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A COVID TEST DONE THROUGH (B)(6) ON MONDAY, (B)(6) 2021. ON THURSDAY, (B)(6) THE RESULTS WERE POSITIVE. I TOOK ANOTHER TEST THAT SAME DAY FROM THE (B)(6) DEPARTMENT OF HEALTH AND HUMAN SERVICES. I RECEIVED THE RESULT THE NEXT MORNING ON FRIDAY (B)(6) AND IT WAS NEGATIVE. I BELIEVE THE FIRST TEST WAS A FALSE POSITIVE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1442577 COVID TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QJR PERKINELMER

    Patients

    Seq Age Sex Outcome Treatment
    1