BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHO PROVUE

    MDR report key: 1080977 · Received July 24, 2008

    Report

    Report Number
    1056600-2008-00243
    Event Type
    Other
    Date Received
    July 24, 2008
    Date of Event
    June 28, 2008
    Report Date
    July 24, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEFINITE ROOT CAUSE WAS DETERMINED. AN OCD FIELD ENGINEER WENT ON SITE AND PERFORMED A PM AND PERFORMED ALL REQUIRED ADJUSTMENTS AND GENERATED A NEW REFERENCE IMAGE. THE FE ALSO REMOVED AND CLEANED THE CAROUSEL SPINNERS. THE INSTRUMENT WAS RETURNED TO EXPECTED OPERATION. THIS CUSTOMER HAS NOT LOGGED ANY COMPLAINTS AGAINST THIS ANALYZER SINCE THE REPAIR.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE REAGENT CAROUSEL IS NOT SPINNING THE RED CELL REAGENTS PROPERLY. THE CAROUSEL IS SPINNING TOO SLOW. NO INDICATION OF ANY INCORRECT RESULTS, INCORRECT VOLUMES OR INCORRECT PROBE DISPENSING. VARIATIONS IN RED BLOOD CELL CONCENTRATIONS MAY AFFECT THE SENSITIVITY OF THE TEST.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1