BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE ANALYZER

    MDR report key: 714484 · Received May 13, 2006

    Report

    Report Number
    1056600-2006-00068
    Event Type
    Malfunction
    Date Received
    May 13, 2006
    Date of Event
    April 12, 2006
    Report Date
    May 12, 2006
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE USER WAS PERFORMING ANTIBODY SCREEN TESTING ON THE THE ORTHO PROVUE ANALYZER AND REPORTED THAT THE PROBE DRIPPED FLUID ON THE FOIL OF THE MTS ANTI-LGG GEL CARD. FLUID ON THE FOIL OF THE GEL CARDS CAN LEAD TO POSSIBLE CARRY OVER / CROSS CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO PROVUE ANALYZER AUTOMATED BLOOD GROUPING AND ANTIBODY TEST SYSTEM KSZ MICRO TYPING SYSTEMS, INC. MTS213784 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other