BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1032013 · Received April 21, 2008

    Report

    Report Number
    1056600-2008-00119
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    March 24, 2008
    Report Date
    April 21, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A POSSIBLE ROOT CAUSE WAS DETERMINED. AN OCD FIELD ENGINEER ARRIVED ON SITE AND DETERMINED THE CONNECTOR WAS DAMAGED AND THE WASH BLOCK WAS CRACKED. REPLACEMENT OF THE PROBE AND WASH BLOCK AND THE APPROPRIATE ADJUSTMENTS HAS RETURNED THE INSTRUMENT TO EXPECTED OPERATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PROBE ON THE ORTHO PROVUE ANALYZER DRIPPED FLUID. THE CUSTOMER INDICATED THE REAGENTS WERE CONTAMINATED. TESTING WAS ABORTED AND 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