BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL

    MDR report key: 19593618 · Received June 24, 2024

    Report

    Report Number
    3004013603-2024-00003
    Event Type
    Malfunction
    Date Received
    June 24, 2024
    Date of Event
    May 7, 2024
    Report Date
    October 22, 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 ADVERSE OUTCOMES WERE 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.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION CONCLUDED THAT DUST/DIRT IN THE INSTRUMENT, POSSIBLY DUE TO CONSTRUCTION IN THE VICINITY, LED TO THE DISCREPANT RESULTS AND THAT THE KIT LOT IS NOT SUSPECT.

    Description of Event or Problem · 0

    DISCREPANT RESULTS FOR FLU A WITH QIASTAT-DX RESPIRATORY PANEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1578066 QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR QIAGEN GMBH 178014042

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown