BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL

    MDR report key: 13001722 · Received December 14, 2021

    Report

    Report Number
    3004013603-2021-00010
    Event Type
    Injury
    Date Received
    December 14, 2021
    Date of Event
    November 12, 2021
    Report Date
    December 14, 2021
    Manufacturer
    QIAGEN GMBH
    Product Code
    QJR
    PMA / PMN Number
    EUA200075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    A SUSPECTED FALSE POSITIVE RESULTS FOR THE SARS-COV-2 TARGET WAS OBTAINED FOR ONE PATIENT WITH THE QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1898974 QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR QIAGEN GMBH 210318

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other