BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XTAG RESPIRATORY VIRAL PANEL

    MDR report key: 6131527 · Received November 23, 2016

    Report

    Report Number
    MW5066367
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    July 12, 2016
    Report Date
    November 23, 2016
    Manufacturer
    LUMINEX MOLECULAR DIAGNOSTICS
    Product Code
    OCC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    REACTIVITY FOR PARAINFLUENZA 2 TARGET WAS REDUCED IN XTAG RESPIRATORY VIRAL PANEL KIT. SUBSEQUENTLY, WHILE TROUBLESHOOTING THIS ISSUE WE NOTICED NEW LOTS ORDERED AS REPLACEMENTS DISPLAYED REDUCED REACTIVITY FOR ADENOVIRUS AND HUMAN METAPNEUMOVIRUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777342 XTAG RESPIRATORY VIRAL PANEL XTAG RESPIRATORY VIRAL PANEL OCC LUMINEX MOLECULAR DIAGNOSTICS MULTIPLE

    Patients

    Seq Age Sex Outcome Treatment
    1