BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1230346 · Received November 7, 2008

    Report

    Report Number
    1056600-2008-00329
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 20, 2008
    Report Date
    November 7, 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

    THE CUSTOMER INDICATED THEY DISCOVERED THAT THE TUBING CONNECTION TO THE WASTE BOTTLE WAS NOT CONNECTED PROPERLY RESULTING IN THE LEAKAGE. THE PROPER CONNECTION TO THE WASTE BOTTLE HAS RETURNED THE ANALYZER TO EXPECTED OPERATION. NO REPAIRS WERE REQUIRED. THE CUSTOMER HAS NOT LOGGED ANY SIMILAR COMPLAINTS AGAINST THIS INSTRUMENT SINCE THIS INCIDENT. INCIDENT IS ISOLATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PROBE OF THE ORTHO PROVUE ANALYZER DRIPPED FLUID INTO THE REAGENT CELLS ON BOARD THE INSTRUMENT. 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