BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 XPI

    MDR report key: 3222951 · Received July 12, 2013

    Report

    Report Number
    2247117-2013-00069
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    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

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC). THE CUSTOMER INFORMED THE TSC SPECIALIST THAT THE LABORATORY STAFF HAD NOT FOLLOWED THE PROTOCOL INDICATED IN THE IMMULITE 2000 OPERATOR'S GUIDE FOR DILUTING ON-BOARD DILUENTS PRIOR TO USING THEM FOR MANUAL DILUTIONS. MANUAL DILUTIONS WERE PERFORMED ON THE CA 125, TG, INSULIN, ATG, ANTI-TPO, DHEA-SO4, AND AFP, WHICH WERE RUN WITH THE CONCENTRATED DILUENT. THE TSC SPECIALIST ADVISED THE CUSTOMER TO CHECK THE RESULTS OBTAINED WITH THE CONCENTRATED DILUENT WITH RESULTS OF THE DILUENT PROPERLY DILUTED. THE CAUSE OF PATIENT SAMPLES BEING RUN WITH CONCENTRATED DILUENT INSTEAD OF PREDILUTED DILUENT IS A USER ERROR. THIS INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    PATIENT SAMPLES WERE RUN WITH CONCENTRATED DILUENT INSTEAD OF PREDILUTED DILUENT ON AN IMMULITE 2000 XPI INSTRUMENT FOR THE FOLLOWING ASSAYS: CANCER ANTIGEN 125 (CA 125), THYROGLOBULIN (TG), INSULIN, ANTI-THYMOCYTE GLOBULIN (ATG), ANTI-THYROID PEROXIDASE (ANTI-TPO), DEHYDROEPIANDROSTERONE SULFATE (DHEA-SO4), AND ALPHA-FETOPROTEIN (AFP). PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN IF ANY OF THE RESULTS WERE DISCORDANT. THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE PATIENT SAMPLES BEING RUN WITH CONCENTRATED DILUENT INSTEAD OF PREDILUTED DILUENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321796 IMMULITE 2000 XPI IMMULITE 2000 XPI JJQ SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000 XPI

    Patients

    Seq Age Sex Outcome Treatment
    1