BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XTAG GASTROINTESTINAL PATHOGEN PANEL (XTAG GPP)

    MDR report key: 3678877 · Received March 6, 2014

    Report

    Report Number
    3678877
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    February 21, 2014
    Report Date
    March 5, 2014
    Manufacturer
    LUMINEX MOLECULAR DIAGNOSTICS
    Product Code
    PCH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US

    Narratives

    Description of Event or Problem · 1

    WE HAVE BEEN GETTING FALSE POSITIVE RESULTS WITH OUR GIARDIA TEST KITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134416 XTAG GASTROINTESTINAL PATHOGEN PANEL (XTAG GPP) GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED PCH LUMINEX MOLECULAR DIAGNOSTICS * IK032C-005
    134417 XTAG GASTROINTESTINAL PATHOGEN PANEL (XTAG GPP) GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED PCH LUMINEX MOLECULAR DIAGNOSTICS * IK032C-007
    134418 XTAG GASTROINTESTINAL PATHOGEN PANEL (XTAG GPP) GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED PCH LUMINEX MOLECULAR DIAGNOSTICS * IK032C-008

    Patients

    Seq Age Sex Outcome Treatment
    1 *