BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1133547 · Received August 21, 2008

    Report

    Report Number
    1056600-2008-00268
    Event Type
    Malfunction
    Date Received
    August 21, 2008
    Date of Event
    July 23, 2008
    Report Date
    August 21, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A POSSIBLE ROOT CAUSE WAS DETERMINED. A FIELD ENGINEER ARRIVED AT THE CUSTOMER SITE AND DETERMINED THAT THE PROBE WAS BENT. A BENT PROBE CAN LEAD TO A LOSS OF VACUUM/PRESSURE IN THE FLUIDICS SYSTEM WHICH COULD RESULT IN PROBE DRIP. REPLACEMENT OF THE PROBE AND ADJUSTMENTS HAS RETURNED THE INSTRUMENT TO ITS EXPECTED OPERATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PROBE ON THE ORTHO PROVUE ANALYZER WAS BENT AND DRIPPING FLUID. THE CUSTOMER ABORTED TESTING. 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 SYST KSZ MICRO TYPING SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1