BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QIAREACH

    MDR report key: 11140389 · Received January 8, 2021

    Report

    Report Number
    1122376-2020-00011
    Event Type
    Malfunction
    Date Received
    January 8, 2021
    Date of Event
    December 21, 2020
    Report Date
    January 8, 2021
    Manufacturer
    QIAGEN SCIENCES, LLC
    Product Code
    QKP
    PMA / PMN Number
    EUA202973
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE RESULTS FROM THIS TEST WERE NOT USED FOR PATIENT REPORTING AND NO ADVERSE OUTCOMES WERE REPORTED, QIAGEN IS REPORTING THIS EVENT IN AN ABUNDANCE OF CAUTION AND IN ACCORDANCE WITH EUA REQUIREMENTS.

    Description of Event or Problem · 1

    SPECIMENS WHICH TESTED POSITIVE AND SPECIMENS WHICH TESTED NEGATIVE WITH QIAREACH SAR-COV-2 ANTIGEN TEST HAD DISCREPANT RESULTS FOR SARS-COV-2 WHEN TESTED BY PCR METHOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36774 QIAREACH SARS-COV-2 ANTIGEN TEST QKP QIAGEN SCIENCES, LLC 86651

    Patients

    Seq Age Sex Outcome Treatment
    1