BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL

    MDR report key: 10255144 · Received July 9, 2020

    Report

    Report Number
    3004013603-2020-00003
    Event Type
    Injury
    Date Received
    July 9, 2020
    Date of Event
    June 11, 2020
    Report Date
    July 9, 2020
    Manufacturer
    QIAGEN GMBH
    Product Code
    QJR
    PMA / PMN Number
    EUA200075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO INJURY WAS REPORTED. PATIENT WAS TREATED AS REQUIRED. THE INVESTIGATION REVEALED NO MALFUNCTION OF THE KIT. QIAGEN IS REPORTING THIS INCIDENT IN AN ABUNDANCE OF CAUTION AND IN ACCORDANCE WITH THE CONDITIONS OF APPROVAL UNDER THE EMERGENCY USE AUTHORIZATION FOR THIS PRODUCT

    Description of Event or Problem · 1

    SARS-COV-2 WAS NOT DETECTED IN ONE PATIENT SAMPLE RUN TWICE USING THE QIASTAT-DX RESPIRATORY SARS-COV- 2 PANEL, WHILE IT WAS DETECTED USING TWO OTHER EUA DIAGNOSTIC KITS. ALL TESTS WERE RUN USING THE SAME SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719454 QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR QIAGEN GMBH 200084

    Patients

    Seq Age Sex Outcome Treatment
    1 Other