BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 ANTI-TG AB

    MDR report key: 2773664 · Received October 5, 2012

    Report

    Report Number
    2432235-2012-00328
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 11, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED
    Product Code
    JZO
    PMA / PMN Number
    K991094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE ANALYZED THE IMMULITE 2000 XPI INSTRUMENT AND FOUND IT TO BE WORKING CORRECTLY. THE FSE RAN THE ATG SAMPLES AND OBTAINED SIMILAR NEGATIVE RESULTS. THE CAUSE OF THE DISCORDANT ATG RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT LOW ANTI-THYROGLOBULIN (ATG) RESULTS WERE OBTAINED ON AN IMMULITE 2000 XPI. THE CUSTOMER RAN TWO PATIENT SAMPLES FOR COMPARISON BETWEEN THEIR OLD INSTRUMENT IMMULITE 2000 XPI AND THEIR ADVIA CENTAUR XP. THE IMMULITE GAVE NEGATIVE RESULTS WHILE THE CENTAUR GAVE POSITIVE RESULTS. FOR CONFIRMATION THE SAMPLES WERE RUN ON A DIFFERENT SYSTEM AND POSITIVE RESULTS WERE OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ATG RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 ANTI-TG AB ANTI-THYROGLOBULIN ANTIBODY JZO SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED ANTI-TG AB 529

    Patients

    Seq Age Sex Outcome Treatment
    1