BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVID 19 PCR TEST

    MDR report key: 10648143 · Received October 7, 2020

    Report

    Report Number
    MW5097135
    Event Type
    Malfunction
    Date Received
    October 7, 2020
    Date of Event
    September 28, 2020
    Report Date
    October 5, 2020
    Manufacturer
    UNK
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FALSE POSITIVE COVID19 PCRT T; I WAS TESTED AT WORK FOR COVID19 WITH A PCR TEST AND 2 DAYS LATER I WAS CALLED AND TOLD IT WAS POSITIVE. SINCE TESTING POSITIVE I HAVE HAD 4 RAPID TESTS, ANOTHER PCR TEST AND AN ANTIBODY TEST, ALL OF WHICH WERE NEGATIVE. I HAVE NEVER HAD A SYMPTOM. WHERE I WORK, THEY TEST EVERY WEEK AND THEY ARE ALWAYS GETTING FALSE POSITIVES ON PEOPLE. I AM THE ONLY ONE AND WENT AND DID ALL THE TESTS I DID BECAUSE I KNOW I DONT HAVE IT. EVEN THE ANTIBODY TEST WAS NEGATIVE. I HAVE DONE ANOTHER ANTIBODY TEST 2ND ONE, ALSO NEGATIVE. THESE TESTS ARE WRONG AND THEY NEED TO BE FIXED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104735 COVID 19 PCR TEST REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other