BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1053199 · Received May 28, 2008

    Report

    Report Number
    1056600-2008-00178
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 28, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A POSSIBLE ROOT CAUSE WAS DETERMINED. AN OCD FIELD ENGINEER WENT TO THE CUSTOMER SITE AND DETERMINED THAT THE PRESSURE WAS OUT OF SPECIFICATIONS AND THE WASH STATION WAS CRACKED. REPLACEMENT OF THE PROBE, WASH STATION AND THE APPROPRIATE ADJUSTMENTS HAS RETURNED THE INSTRUMENT 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 INDICATED THAT THE PROBE ON THE ORTHO PROVUE ANALYZER WAS NOT DISPENSING THE CORRECT AMOUNT OF FLUID INTO THE MTS GEL CARDS. NO ERRONEOUS RESULTS WERE REPORTED. INCORRECT OR NO DISPENSE CAN LEAD TO ERRONEOUS TEST RESULTS AND 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