BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1111616 · Received August 13, 2008

    Report

    Report Number
    1056600-2008-00260
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 16, 2008
    Report Date
    August 13, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A POSSIBLE ROOT CAUSE WAS DETERMINED. AN OCD FIELD ENGINEER ARRIVED AT THE CUSTOMER SITE AND DETERMINED THE PROBE AND SYRINGE WERE LEAKING. THE FE MADE NECESSARY REPAIRS/REPLACEMENTS AND RETURNED THE ANALYZER TO EXPECTED OPERATION. THIS CUSTOMER HAS NOT LOGGED ANY SIMILAR COMPLAINTS AGAINST THE ANALYZER SINCE THE INCIDENT. (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PROBE OF THE ORTHO PROVUE ANALYZER LEAKED FLUID INTO THE SCREENING CELLS AND THE "AFFIRMAGEN". THERE WAS NO INDICATION ERRONEOUS RESULTS WERE REPORTED, AND NO BIOHAZARD EXPOSURE OCCURRED. 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.

    Patients

    Seq Age Sex Outcome Treatment
    1