BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL

    MDR report key: 14196572 · Received April 25, 2022

    Report

    Report Number
    3004013603-2022-00001
    Event Type
    Malfunction
    Date Received
    April 25, 2022
    Date of Event
    March 31, 2022
    Report Date
    April 25, 2022
    Manufacturer
    QIAGEN GMBH
    Product Code
    QJR
    PMA / PMN Number
    EUA200075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. SAMPLE RESULTS HAD A CT >30 FOR BORDETELLA PERTUSSIS. THE IFU INSTRUCTS USERS TO DO A CONFIRMATORY SPECIFICITY TEST FOR SAMPLES WITH CT > 29.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127581 QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR QIAGEN GMBH 172012430

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other