BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL

    MDR report key: 12583156 · Received October 6, 2021

    Report

    Report Number
    3004013603-2021-00008
    Event Type
    Injury
    Date Received
    October 6, 2021
    Date of Event
    August 31, 2021
    Report Date
    October 6, 2021
    Manufacturer
    QIAGEN GMBH
    Product Code
    QJR
    PMA / PMN Number
    EUA200075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. SAMPLE RESULTS HAD A CT >30 FOR BORDETELLA PERTUSSIS. THE IFU INSTRUCTS USERS TO DO A CONFIRMATORY SPECIFICITY TEST FOR SAMPLES WITH 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. RETESTING DELAY AND UNKNOWN STORAGE CONDITIONS BETWEEN RETESTS MAY IMPACT RESULT OUTCOME AND CONTRIBUTE FURTHER TO DISCREPANCIES BETWEEN DIFFERENT ASSAY METHODOLOGIES.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1482005 QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR QIAGEN GMBH 210292

    Patients

    Seq Age Sex Outcome Treatment
    1 Other