BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QIAREACH

    MDR report key: 11140391 · Received January 8, 2021

    Report

    Report Number
    1122376-2020-00008
    Event Type
    Malfunction
    Date Received
    January 8, 2021
    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
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL SPECIMENS WERE COLLECTED IN AZER VTM, ALTHOUGH NOT LISTED IN INTENDED USE STATEMENT FOR THE PRODUCT, IS MADE TO THE CDC FORMULATION. 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
    37038 QIAREACH SARS-COV-2 ANTIGEN TEST QKP QIAGEN SCIENCES, LLC 86651

    Patients

    Seq Age Sex Outcome Treatment
    1