BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 2070475 · Received April 27, 2011

    Report

    Report Number
    1056600-2011-00037
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 27, 2011
    Report Date
    April 27, 2011
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE AND CHECKED THE TEMPERATURE ON BOTH INCUBATOR BLOCKS, THE CENTRIFUGE SPEED, THE PRESSURE, THE VACUUM, AND THE READER CAMERA. NO CHANGE NEEDED. THE FE SENT LOG, IMAGES OF REACTIONS, AND REFERENCE IMAGE FROM THE PROVUE TO CTS SECOND LEVEL SUPPORT SPECIALIST. QC WAS RUN AND ALL ACTIONS TAKEN WHERE VERIFIED WITH THE CUSTOMER. INSTRUMENT IS OPERATING AS EXPECTED. NO REPAIRS NEEDED. (B)(4).

    Description of Event or Problem · 1

    THE PROVUE MISSED AN ANTIBODY THAT WAS DETECTED IN MANUAL GEL IN THE ANTIBODY SCREEN TEST. NO ERRONEOUS RESULTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ MICROTYPING SYSTEMS 3.1.1

    Patients

    Seq Age Sex Outcome Treatment
    1