BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1935785 · Received December 22, 2010

    Report

    Report Number
    1056600-2010-00141
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 29, 2010
    Report Date
    December 22, 2010
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2010 THE CUSTOMER REPORTED AN INITIALIZATION ISSUE WITH THE INSTRUMENT (COMPLAINT: (B)(4)). A SERVICE ORDER WAS CREATED ON (B)(6) 2010. ON (B)(6) 2010 WITH NO REPAIRS TO THE INSTRUMENT THE CUSTOMER DECIDED TO RUN QUALITY CONTROL AND 2 PATIENT SAMPLES. ON (B)(6) 2010 THE FIELD ENGINEER PERFORMED SERVICE ON THE INSTRUMENT. REPAIRS HAVE RETURNED THE INSTRUMENT TO EXPECTED OPERATION (COMPLAINT: (B)(4) FOR DETAILS). CTS DISCUSSED WITH THE CUSTOMER THE IMPORTANCE OF NOT USING THE INSTRUMENT UNTIL SERVICE IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT WITH A NEGATIVE ANTIBODY SCREEN REACTED POSITIVE WHEN TESTED ON THE PROVUE. INCORRECT RESULTS WERE REPORTED TO THE PHYSICIAN. THIS ISSUE OCCURRED ON A DEFECTIVE INSTRUMENT THAT WAS AWAITING SERVICE (COMPLAINT : (B)(4)). BEFORE SERVICE COULD BE PERFORMED THE CUSTOMER DECIDED TO USE THE INSTRUMENT TO RUN QC AND PATIENT SAMPLES.

    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