BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL

    MDR report key: 19031140 · Received April 3, 2024

    Report

    Report Number
    3004013603-2024-00002
    Event Type
    Malfunction
    Date Received
    April 3, 2024
    Date of Event
    February 16, 2024
    Report Date
    April 3, 2024
    Manufacturer
    QIAGEN GMBH
    Product Code
    QJR
    PMA / PMN Number
    EUA200075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO SERIOUS INJURIES RELATED TO THE DEVICE 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 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. THE IFU INSTRUCTS USERS TO DO A CONFIRMATORY SPECIFICITY TEST FOR CT>29 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 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. THE IFU INSTRUCTS USERS TO DO A CONFIRMATORY SPECIFICITY TEST FOR CT>29. (TECHNICAL ISSUES WITH ESG DELAYED SUBMISSION)

    Description of Event or Problem · 0

    DISCREPANT RESULTS FOR BORDETELLA PERTUSSIS BETWEEN THE QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL AND ALTERNATIVE METHOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1689283 QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR QIAGEN GMBH 175035577

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other