BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1002803 · Received February 26, 2008

    Report

    Report Number
    1056600-2008-00066
    Event Type
    Malfunction
    Date Received
    February 26, 2008
    Date of Event
    January 29, 2008
    Report Date
    February 26, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A POSSIBLE ROOT CAUSE WAS DETERMINED. AN OCD FIELD ENGINEER ARRIVED AT THE CUSTOMER SITE AND DETERMINED THAT THE TUBING CONNECTIONS FROM THE FLUIDICS SYSTEM WASH/WASTE BOTTLE WERE INTERCHANGED AND THE PRESSURE WAS SLIGHTLY OUT OF RANGE. THE FE PERFORMED THE APPROPRIATE SERVICE TO RETURN THE INSTRUMENT TO EXPECTED OPERATIONS. INCIDENT OCCURRED AS A RESULT OF USER ERROR. THIS CUSTOMER HAS NOT LOGGED ANY COMPLAINTS AGAINST THIS ANALYZER SINCE THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PROBE LEAKED FLUID FROM THE HANDLER AND THE DILUTION CUP OVERFLOWED ON THE ORTHO PROVUE ANALYZER. ALL TESTING WAS ABORTED. 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. THE USER DETECTED THE ISSUE, PREVENTING ERRONEOUS RESULTS FROM BEING REPORTED

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1