BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PCR TEST QUANTIVIRUSTM SARS-COV-2

    MDR report key: 11776246 · Received May 4, 2021

    Report

    Report Number
    MW5101143
    Event Type
    Injury
    Date Received
    May 4, 2021
    Date of Event
    April 15, 2021
    Report Date
    May 3, 2021
    Manufacturer
    DIACARTA, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PCR TESTING FLAWED. FALSE POSITIVE GIVEN. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670353 PCR TEST QUANTIVIRUSTM SARS-COV-2 REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR DIACARTA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Disability