BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL

    MDR report key: 10393957 · Received August 11, 2020

    Report

    Report Number
    3004013603-2020-00011
    Event Type
    Injury
    Date Received
    August 11, 2020
    Date of Event
    July 18, 2020
    Report Date
    August 11, 2020
    Manufacturer
    QIAGEN GMBH
    Product Code
    QJR
    PMA / PMN Number
    EUA200075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO INJURY WAS REPORTED. 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

    SUSPECTED FALSE NEGATIVE RESULTS FOR SARS-COV-2 WERE OBTAINED FOR 5 PATIENT SAMPLES WITH THE QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL, MAT. 691214.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853458 QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR QIAGEN GMBH 200132

    Patients

    Seq Age Sex Outcome Treatment
    1 Other