BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000

    MDR report key: 3233446 · Received July 18, 2013

    Report

    Report Number
    2247117-2013-00076
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 21, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LOJ
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE FSE CALIBRATED THE BARCODE READ POSITION AND CONFIRMED THAT THE BARCODE READER WAS READING THE RACK IDENTIFIER PROPERLY. THE FSE COLLECTED THE INSTRUMENT DATA FILES, WHICH WERE REVIEWED BY A SIEMENS GLOBAL PRODUCT SUPPORT (GPS) SPECIALIST. AFTER EVALUATION OF THE DATA FILES, THE GPS SPECIALIST DID NOT FIND AN INSTRUMENT MALFUNCTION. THE CAUSE OF THE RACK IDENTIFIER BEING READ INCORRECTLY IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    PATIENT SAMPLES WERE TESTED FOR ALPHA FETOPROTEIN (AFP) ON AN IMMULITE 2000 INSTRUMENT, AND THE RESULTS PRINTED WITH 'N/A' IN THE COLUMN INDICATING SAMPLE POSITION. THE ACCESSION NUMBERS AND RESULTS WERE PRESENT ON THE PRINT-OUTS. THE SAMPLES WERE RERUN AND RESULTED THE SAME. IT IS UNKNOWN IF ANY RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE RACK IDENTIFIER BEING READ INCORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333321 IMMULITE 2000 IMMULITE 2000 LOJ SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000

    Patients

    Seq Age Sex Outcome Treatment
    1