BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1883273 · Received October 26, 2010

    Report

    Report Number
    1056600-2010-00126
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 26, 2010
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE AND REPLACED THE SYRINGE, PROBE, AND WASH STATION. THE FE PERFORMED THE PROBE ADJUSTMENT. THE FE ALSO PERFORMED THE READER CAMERA ALIGNMENT, OPTIC AND FINE OPTIC ADJUSTMENTS. THE FE MADE NEW REFERENCE IMAGE. THE PROVUE WAS ABLE TO RUN WITHOUT ERROR. REPAIRS HAVE RETURNED THIS INSTRUMENT TO EXPECTED OPERATION. (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ORTHO PROVUE MISSED AN ANTIBODY THAT WAS DETECTED IN MANUAL GEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ MICROTYPING SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1