BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1133546 · Received August 21, 2008

    Report

    Report Number
    1056600-2008-00269
    Event Type
    Malfunction
    Date Received
    August 21, 2008
    Date of Event
    July 28, 2008
    Report Date
    August 21, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEFINITIVE ROOT CAUSE WAS DETERMINED. AN OCD FIELD ENGINEER (FSE) VISITED THE SITE. THE FE REVIEWED THE PROVUE LOG FILES AND REPORTED THAT THE ANALYZER POSTED MULTIPLE ERROR MESSAGES FOR "XYZERRCOD G" (CURRENT LIMIT OF GRIPPER MOTOR). THE FE REPLACED THE PROBE, WASH STATION AND PERFORMED THE NECESSARY REPAIRS AND ADJUSTMENTS TO RETURN THE INSTRUMENT 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 THEY OBSERVED RED CELL DROPLETS ON TOP OF THE MTS GEL CARD FOIL DURING TESTING ON THE ORTHO PROVUE ANALYZER. UPON INVESTIGATION, THE CUSTOMER INDICATED RED CELLS WERE NOT DISPENSED INTO ONE OF THE GEL CARDS. THE ANALYZER POSTED MULTIPLE ERROR MESSAGES. NO ERRONEOUS RESULTS WERE REPORTED. FLUID ON THE TOP OF THE GEL CARD FOIL CAN LEAD TO CARRY OVER AND/OR CROSS CONTAMINATION, WHICH CAN LEAD TO ERRONEOUS TEST RESULTS AND TRANSFUSION OF INCOMPATIBLE BLOOD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1