BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1053235 · Received May 28, 2008

    Report

    Report Number
    1056600-2008-00180
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 28, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A POSSIBLE ROOT CAUSE WAS DETERMINED. AN OCD FIELD ENGINEER ARRIVED AT THE SITE AND DETERMINED THAT THE GEL CARDS WERE TILTED FROM BOTH THE INCUBATOR AND THE CENTRIFUGE. THE FE PERFORMED GRIPPER AND CAMERA ADJUSTMENTS AND REPLACED THE APPROPRIATE COMPONENTS TO RETURN THE ANALYZER TO EXPECTED OPERATION. THIS CUSTOMER HAS NOT LOGGED ANY COMPLAINTS AGAINST THIS ANALYZER SINCE THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ORTHO PROVUE ANALYZER RESULTED NEGATIVE TYPE AND ANTIBODY SCREEN RESULTS AS FALSE POSITIVES AND MIXED FIELD REACTIONS. THE GEL CARDS WERE BROUGHT TO THE SERVICE RACK FOR MANUAL REVIEW. THE CUSTOMER MANUALLY REVIEWED THE GEL CARDS, AND INDICATED THE RESULTS WERE NEGATIVE. NO ERRONEOUS RESULTS WERE REPORTED. FALSE POSITIVE RESULTS MAY RESULT IN ABO MISCLASSIFICATION AND THE TRANSFUSION OF INCOMPATIBLE BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYST KSZ MICRO TYPING SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1