BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 XPI

    MDR report key: 3833555 · Received May 27, 2014

    Report

    Report Number
    2247117-2014-00030
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 9, 2014
    Report Date
    May 2, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJQ
    PMA / PMN Number
    P010053/S007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEADQUARTER SUPPORT CENTER (HSC) SPECIALIST REVIEWED THE CUSTOMER DATA AND THE INSTRUMENT FILES. THE INSTRUMENT FILES INDICATED THE POSSIBILITY OF "AIR BUBBLE" IN THE SAMPLE DUE TO THE DIFFERENCE IN HEIGHTS DURING SAMPLE ASPIRATION THE FIRST TIME THE SAMPLE WAS RUN AND THE REPEAT RUN. THE HSC ADVISED THE CUSTOMER TO REVIEW THEIR SAMPLE HANDLING PROCEDURE AS INDICATED IN THE OPERATOR'S MANUAL. A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE CHECKED THE SUBSTRATE PUMP, REAGENT AND SAMPLE PROBE DISPENSE ANGLES, DUAL RESOLUTION DILUTOR POSITIONS, SPEED AND TUBE LIFTER POSITIONS. THE FSE DID NOT FIND ANY MECHANICAL ISSUES WITH THE INSTRUMENT. HSC CONTACTED THE CUSTOMER SITE AND THE CUSTOMER INFORMED HSC THAT THEY HAD NOT ENCOUNTERED ANY MORE DISCORDANT RESULTS. THE CAUSE OF THE FALSELY LOW RESULT ON THE ONE PATIENT SAMPLE IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED FALSELY LOW VALUES ON ONE PATIENT SAMPLE FOR THYROID STIMULATING HORMONE (TSH) AND FREE THYROXINE (FT4) ON AN IMMULITE 2000 XPI INSTRUMENT. THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT AND THE RESULTS WERE HIGHER. THE FALSELY LOW RESULTS FOR TSH AND FT4 WERE NOT REPORTED TO THE PHYSICIAN(S). IT IS NOT KNOWN IF THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY LOW TSH AND FT4 RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310263 IMMULITE 2000 XPI IMMULITE 2000 XPI JJQ SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 2000 XPI

    Patients

    Seq Age Sex Outcome Treatment
    1