BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL

    MDR report key: 15454741 · Received September 20, 2022

    Report

    Report Number
    3004013603-2022-00005
    Event Type
    Malfunction
    Date Received
    September 20, 2022
    Date of Event
    August 10, 2022
    Report Date
    September 9, 2022
    Manufacturer
    QIAGEN GMBH
    Product Code
    QJR
    PMA / PMN Number
    EUA200075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 RESULTS FOR BORDETELLA PERTUSSIS HAD A CT >30. THE IFU INSTRUCTS USERS TO DO A CONFIRMATORY SPECIFICITY TEST FOR CT>29. 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

    A SUSPECTED FALSE POSITIVE BORDETELLA PERTUSSIS RESULT WAS OBSERVED IN 2 PATIENT SAMPLES WITH THE QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL, MAT. 691223, LOT 172024081.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2698798 QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR QIAGEN GMBH 172024081

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other