BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000

    MDR report key: 3241378 · Received July 22, 2013

    Report

    Report Number
    2247117-2013-00078
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 26, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJQ
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REFUSED SERVICING BY SIEMENS. THE CUSTOMER CONFIRMED NO ISSUES WITH THE OTHER ASSAYS AND NO ERRORS IN THE EVENT LOG. THE CUSTOMER STATED THAT THE QUALITY CONTROLS WERE IN RANGE ON THE FIRST DAY THE SAMPLES WERE RUN. THE CAUSE OF THE DISCORDANT, FALSELY LOW FSH AND PRL RESULTS IS UNKNOWN. THE CUSTOMER IS FINDING THE RESULTS CURRENTLY BEING OBTAINED ARE AS EXPECTED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY LOW FOLLICLE STIMULATING HORMONE (FSH) AND PROLACTIN (PRL) RESULTS WERE OBTAINED FOR TWO PATIENT SAMPLES ON AN IMMULITE 2000 INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE RERUN THE NEXT DAY ON THE SAME INSTRUMENT AND RESULTED HIGHER THEN THE INITIAL RESULTS. THE RERUN RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW FSH AND PRL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340335 IMMULITE 2000 CLINICAL CHEMISTRY JJQ SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000

    Patients

    Seq Age Sex Outcome Treatment
    1