BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1191804 · Received October 1, 2008

    Report

    Report Number
    1056600-2008-00308
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    September 8, 2008
    Report Date
    October 1, 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. AN OCD FIELD ENGINEER ARRIVED AT THE SITE AND DETERMINED THE PROBE WAS BENT. A BENT PROBE CAN LEAD TO A LOSS OF VACUUM/PRESSURE IN THE FLUIDICS SYSTEM WHICH COULD RESULTS IN PROBE DRIP. THE FE REPLACED THE PROBE AS WELL AS THE WASH STATION, PUMP SILENCERS, SYRINGE AND LOWER DOOR FASTENER. A PM AND DIAGNOSTIC TESTS WERE PERFORMED. THE INSTRUMENT WAS RETURNED TO EXPECTED OPERATION. THIS CUSTOMER HAS NOT LOGGED ANY SIMILAR COMPLAINTS AGAINST THIS ANALYZER SINCE THIS INCIDENT. (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A BENT PROBE AND LEAK FROM THE PROBE HOUSING. CUSTOMER DID NOT PROVIDE ANY INFO REGARDING POSSIBLE ERROR CODES. 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