BEUDAMED
    FDA Adverse Event Death Summary report: N

    XTAG RESPIRATORY VIRAL PANEL RVP

    MDR report key: 2392879 · Received December 19, 2011

    Report

    Report Number
    2392879
    Event Type
    Death
    Date Received
    December 19, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 23, 2011
    Manufacturer
    LUMINEX MOLECULAR DIAGNOSTICS, INC.
    Product Code
    OCC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE REPORTER TO US ON 2/23/2011. "(B)(6), ADMITTED ON (B)(6) 2011. ON (B)(6) 2011 - RESPIRATORY VIRAL PANEL (MOLECULAR TEST) ON NASAL WASH SENT TO VIRACOR - RESULTS ARE NEGATIVE. ON (B)(6) 2011 - RESPIRATORY VIRAL PANEL (MOLECULAR TEST) ON NASAL WASH SENT TO VIRACOR - RESULTS ARE NEGATIVE. ON (B)(6) 2011 - RAPID RSV ASSAY POSITIVE AT IN-HOUSE LAB. ON (B)(6) 2011 - PATIENT DIED DUE TO MULTIPLE COMPLICATIONS". FILED REPORT W/FDA ON MARCH 4, 2011 ON THE 'VOLUNTARY' REPORTING FORM AND RECEIVED ATTACHED CONFIRMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XTAG RESPIRATORY VIRAL PANEL RVP XTAG RVP ASSAY OCC LUMINEX MOLECULAR DIAGNOSTICS, INC. NA IK019C-0021

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death