BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1133514 · Received August 21, 2008

    Report

    Report Number
    1056600-2008-00263
    Event Type
    Malfunction
    Date Received
    August 21, 2008
    Date of Event
    July 25, 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 WENT TO THE CUSTOMER SITE AND FOUND THE EVIDENCE OF LEAKING AROUND THE SYRINGE. THE FE REPLACED THE SYRINGE, PROBE, AND WASH STATION AND PERFORMED THE APPROPRIATE ADJUSTMENTS TO RETURN THE INSTRUMENT TO EXPECTED OPERATION. THIS CUSTOMER HAS NOT LOGGED ANY SIMILAR COMPLAINTS AGAINST THIS ANALYZER SINCE THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ORTHO PROVUE ANALYZER WAS INTERMITTENTLY NOT DISPENSING RED CELLS INTO THE MTS POLYSPECIFIC CARDS DURING QC TESTING. TESTING WAS ABORTED. NO ERRONEOUS RESULTS WERE REPORTED. INCORRECT OR NO DISPENSE 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

    Patients

    Seq Age Sex Outcome Treatment
    1