BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000XPI

    MDR report key: 2535865 · Received April 15, 2012

    Report

    Report Number
    2247117-2012-00027
    Event Type
    Malfunction
    Date Received
    April 15, 2012
    Date of Event
    March 21, 2012
    Report Date
    March 21, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K970227
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED SIEMENS REGIONAL CUSTOMER SUPPORT REGARDING THIS ISSUE. THE CAUSE OF THE DISCORDANT ATG RESULTS IS UNKNOWN. THE CUSTOMER IS CURRENTLY RUNNING ANTI-THYROGLOBULIN ANTIBODIES TESTING ON THE ADVIA CENTAUR ANALYZER.

    Description of Event or Problem · 1

    DISCORDANT ANTI-THRYOGLOBULIN ANTIBODIES (ATG) RESULTS WERE OBTAINED WITH 4 PATIENT SAMPLES ON AN IMMULITE 2000 XPI ANALYZER. THE LABORATORY ALSO TESTED THE SAMPLES ON THEIR ADVIA CENTAUR INSTRUMENT AND OBTAINED DIFFERENT RESULTS. THE CUSTOMER CONSIDERS THE IMMULITE 2000 XPI ATG RESULTS TO BE DISCORDANT WITH THE ADVIA CENTAUR ATG RESULTS. THE DISCORDANT RESULTS WERE NOT REPORTED. THE ADVIA CENTAUR ATG RESULTS WERE REPORTED TO THE PHYSICIAN. THERE WERE NO KNOWN REPORTS OF PATIENT TREATMENT BEING ALTERED, DELAYED, OR WITHHELD DUE TO THE DISCORDANT ATG RESULTS. THERE WERE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ATG RESULTS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000XPI IMMUNO-ASSAY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000XPI 505, 506

    Patients

    Seq Age Sex Outcome Treatment
    1