BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QIAREACH

    MDR report key: 11275333 · Received February 3, 2021

    Report

    Report Number
    1122376-2021-00008
    Event Type
    Malfunction
    Date Received
    February 3, 2021
    Report Date
    February 3, 2021
    Manufacturer
    QIAGEN SCIENCES, LLC
    Product Code
    QKP
    PMA / PMN Number
    EUA202973
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH 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 ON QIAREACH SARS-COV-2 AG TEST WERE TESTED BY PCR METHOD AND WERE NEGATIVE FOR SARS-COV-2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170554 QIAREACH SARS-COV-2 ANTIGEN TEST QKP QIAGEN SCIENCES, LLC 86659

    Patients

    Seq Age Sex Outcome Treatment
    1