BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1203406 · Received October 16, 2008

    Report

    Report Number
    1056600-2008-00317
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 23, 2008
    Report Date
    October 17, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN OCD FIELD ENGINEER ARRIVED AT THE CUSTOMER SITE AND REPLACED THE CRACKED WASH STATION, PERFORMED ADJUSTMENTS TO THE PRESSURE REGULATOR AND PERFORMED ADDITIONAL REPAIRS TO RETURN THE ANALYZER TO EXPECT 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 PROBE ON THE ORTHO PROVUE ANALYZER DRIPPED FLUID, RESULTING IN REAGENT CONTAMINATION. ERRONEOUS RESULTS WERE NOT 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