BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QIAREACH

    MDR report key: 11210456 · Received January 21, 2021

    Report

    Report Number
    1122376-2021-00001
    Event Type
    Malfunction
    Date Received
    January 21, 2021
    Date of Event
    December 11, 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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE COLLECTED USING NASOPHARYNGEAL COLLECTION AND VIRAL TRANSPORT MEDIUM FROM BECTON-DICKINSON. CUSTOMER GAVE NO INDICATION THAT THE PATIENTS WERE SYMPTOMATIC. THE PRODUCT IS INTENDED FOR TESTING SPECIMENS FROM INDIVIDUALS WHO ARE SUSPECTED OF COVID-19 BY THEIR HEALTHCARE PROVIDER. 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 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
    106018 QIAREACH SARS-COV-2 ANTIGEN TEST QKP QIAGEN SCIENCES, LLC 86652

    Patients

    Seq Age Sex Outcome Treatment
    1