BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL

    MDR report key: 11237520 · Received January 27, 2021

    Report

    Report Number
    3004013603-2021-00001
    Event Type
    Injury
    Date Received
    January 27, 2021
    Date of Event
    January 4, 2021
    Report Date
    January 27, 2021
    Manufacturer
    QIAGEN GMBH
    Product Code
    QJR
    PMA / PMN Number
    EUA200075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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

    A SUSPECTED FALSE NEGATIVE RESULT FOR THE SARS-COV-2 TARGET OBTAINED FOR 1 PATIENT SAMPLE WITH THE QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136525 QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR QIAGEN GMBH 166032129

    Patients

    Seq Age Sex Outcome Treatment
    1 Other