BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL

    MDR report key: 10311868 · Received July 22, 2020

    Report

    Report Number
    3004013603-2020-00006
    Event Type
    Injury
    Date Received
    July 22, 2020
    Date of Event
    June 19, 2020
    Report Date
    July 24, 2020
    Manufacturer
    QIAGEN GMBH
    Product Code
    QJR
    PMA / PMN Number
    EUA200075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. THE SAMPLE RESULTS HAD A CT >30. THE IFU INSTRUCTS USERS TO DO A CONFIRMATORY SPECIFICITY TEST FOR A CT>29.

    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. THE SAMPLE RESULT HAD A CT >30. THE IFU INSTRUCTS USERS TO DO A CONFIRMATORY SPECIFICITY TEST FOR A CT>29.

    Description of Event or Problem · 1

    A SUSPECTED FALSE POSITIVE RESULT FOR BORDETELLA PERTUSSIS WAS OBTAINED FOR 1 PATIENT SAMPLE WITH THE QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL, MAT. 691223.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775730 QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR QIAGEN GMBH 166023368

    Patients

    Seq Age Sex Outcome Treatment
    1 Other