BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL

    MDR report key: 14525894 · Received May 27, 2022

    Report

    Report Number
    3004013603-2022-00002
    Event Type
    Injury
    Date Received
    May 27, 2022
    Date of Event
    May 2, 2022
    Report Date
    May 27, 2022
    Manufacturer
    QIAGEN GMBH
    Product Code
    QJR
    PMA / PMN Number
    EUA200075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. THE QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL HEALTHCARE PROVIDER FACT SHEET PUBLISHED ALONGSIDE THE IFU STATES LABORATORY TEST RESULTS SHOULD ALWAYS BE CONSIDERED IN THE CONTEXT OF CLINICAL OBSERVATIONS AND EPIDEMIOLOGICAL DATA IN MAKING A FINAL DIAGNOSIS AND PATIENT MANAGEMENT DECISIONS.

    Description of Event or Problem · 0

    FALSE POSITIVE RESULTS WITH SIMILAR CTS WERE REPORTED FOR ONE PATIENT SAMPLE WITH THE QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1993180 QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR QIAGEN GMBH 172014617

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other