BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 XPI

    MDR report key: 3061645 · Received April 16, 2013

    Report

    Report Number
    2247117-2013-00037
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 26, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJQ
    PMA / PMN Number
    P010053/S007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GLOBAL PRODUCT SUPPORT (GPS) SPECIALIST EVALUATED DATA FROM THE INSTRUMENT AND FOUND NO INSTRUMENT MALFUNCTION. A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE OBSERVED THAT THE REAGENT DRD (DUAL RESOLUTION DILUTOR) HAD MICROBUBBLES. THE DRD WAS REMOVED, CLEANED, PRIMED AND DISPENSE ANGLES WERE TESTED. THE FSE RAN A QUALITY CONTROL AND PRECISION RUN, ALL OF WHICH WERE WITHIN RANGE. THE CAUSE OF THE DISCORDANT, FALSELY LOW AFP RESULT IS UNKNOWN. THIS INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT FALSELY LOW ALPHA-FETOPROTEIN (AFP) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT. THE PATIENT SAMPLE WAS TESTED FOUR TIMES IN ONE RUN. THE FIRST, THIRD, AND FOURTH RESULTS CORRELATED WELL WITH THE PATIENT'S HISTORY. THE SECOND RESULT DID NOT. THE DISCORDANT LOW AFP RESULT ON THE PATIENT SAMPLE WAS NOT RELEASED TO THE PHYSICIAN(S). THE RESULTS THAT CORRELATED AND WERE CONSISTENT WITH PATIENT HISTORY WERE RELEASED TO THE PHYSICIAN(S). THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW AFP RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163695 IMMULITE 2000 XPI IMMULITE 2000 XPI JJQ SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 2000 XPI

    Patients

    Seq Age Sex Outcome Treatment
    1