BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL

    MDR report key: 16852360 · Received May 2, 2023

    Report

    Report Number
    3004013603-2023-00006
    Event Type
    Malfunction
    Date Received
    May 2, 2023
    Date of Event
    April 2, 2023
    Report Date
    May 2, 2023
    Manufacturer
    QIAGEN GMBH
    Product Code
    QJR
    PMA / PMN Number
    EUA200075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO INJURIES WERE REPORTED. QIAGEN IS REPORTING THE INCIDENT IN AN ABUNDANCE OF CAUTION AND IN ACCORDANCE WITH THE CONDITIONS OF AUTHORIZATION 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

    SUSPECTED FALSE POSITIVE RESULTS FOR BORDETELLA PERTUSSIS WITH THE QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1534643 QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR QIAGEN GMBH 172045426

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown