BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL

    MDR report key: 20726807 · Received November 19, 2024

    Report

    Report Number
    3004013603-2024-00004
    Event Type
    Malfunction
    Date Received
    November 19, 2024
    Date of Event
    September 3, 2024
    Report Date
    November 19, 2024
    Manufacturer
    QIAGEN GMBH
    Product Code
    QJR
    PMA / PMN Number
    EUA200075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 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. DUST ON SENSOR OF THE INSTRUMENT WAS DETERMINED TO BE THE MOST LIKELY CAUSE OF THE FALSE POSITIVE. THE TEST WAS USED ON A NON-SYMPTOMATIC PATIENT. THE QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL IS INTENDED FOR TESTING SAMPLES OBTAINED FROM INDIVIDUALS WITH CLINICAL SIGNS AND SYMPTOMS OF RESPIRATORY TRACT INFECTIONS, INCLUDING SARS-COV-2.

    Description of Event or Problem · 0

    SUSPECTED FALSE POSITIVE RESULT OF SARS-COV WITH THE QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2431364 QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR QIAGEN GMBH 178022105

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown