BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QIAREACH

    MDR report key: 11275433 · Received February 3, 2021

    Report

    Report Number
    1122376-2021-00007
    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
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS PERFORMING VALIDATION OF TEST WITH THE SPECIMENS. NO PATIENT RESULTS REPORTED. 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

    FALSE POSITIVE RESULTS ON QIAREACH SARS-COV-2 AG TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168119 QIAREACH SARS-COV-2 ANTIGEN TEST QKP QIAGEN SCIENCES, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1