BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1030494 · Received April 17, 2008

    Report

    Report Number
    1056600-2008-00118
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    March 20, 2008
    Report Date
    April 17, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEFINITIVE ROOT CAUSE WAS DETERMINED. AN OCD FIELD ENGINEER VERIFIED THE VACUUM AND PRESSURE WERE WITHIN SPECIFICATIONS. THE FE REPORTED EVIDENCE OF FLUID LEAKAGE. REPLACEMENT OF THE APPROPRIATE COMPONENTS AND THE NECESSARY ADJUSTMENTS HAS RETURNED 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 WHILE ATTEMPTING TO PERFORM TESTING DROPLETS OF FLUID ON TOP OF THE GEL CARD FOIL WERE OBSERVED WITHOUT RECEIVING AN ERROR MESSAGE. TESTING WAS ABORTED AND DRIPPING WAS NOTED FROM THE PROBE HOUSING STATION. NO ERRONEOUS RESULTS WERE REPORTED. PROBE DRIP MAY LEAD TO DILUTION OF SAMPLE/REAGENT, CARRY OVER AND/OR CROSS CONTAMINATION AND ERRONEOUS RESULTS WHICH COULD LEAD TO 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