BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 2232892 · Received September 2, 2011

    Report

    Report Number
    1056600-2011-00078
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 17, 2011
    Report Date
    September 2, 2011
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CTS REQUESTED THE CUSTOMER TO REPEAT THE MANUAL GEL TESTING USING CELLS ASPIRATED FROM BOTH THE TOP AND THE BOTTOM OF THE RED CELL. THE CUSTOMER PERFORMED THE TESTING AS CTS REQUESTED. THE SAME LOT OF GEL CARDS AND DILUENTS WERE USED FOR BOTH TESTING. THE CELLS FROM THE UPPER PORTION RESULTED AS RH POS, MIXED FIELD. THE CELLS FROM THE LOWER PORTION RESULTED AS RH NEG. NO ERRONEOUS RESULTS WERE REPORTED. THE CUSTOMER IS CONFIDENT THAT THE PROVUE IS OPERATING AS EXPECTED. THE CUSTOMER IS CONFIDENT THE ISSUE IS THE RESULT OF THE MIXED DONOR POPULATION IN THE SAMPLE AS DEMONSTRATED BY THE MANUAL GEL TESTING AND THE ISSUE IS ISOLATED TO THIS ONE SAMPLE. THE CUSTOMER IS SATISFIED WITH THE DISCUSSION AND WITH TROUBLESHOOTING ASSISTANCE. NO SERVICE REQUESTED OR NEEDED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTS FALSE NEGATIVE REACTIVITY WITH THE ANTI-D. NO ERRONEOUS RESULTS WERE REPORTED. NO HARM TO ANY PATIENT.

    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