BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 XPI

    MDR report key: 3830689 · Received May 23, 2014

    Report

    Report Number
    2247117-2014-00028
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    SIEMENS HEALTCHCARE DIAGNOSTICS INC
    Product Code
    JJQ
    PMA / PMN Number
    P010053/S007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). THE CUSTOMER STATED THAT UPON EVALUATION OF THE ERRORS OBTAINED ON PATIENT SAMPLES, IT WAS DISCOVERED THAT THE COUNT PER SECOND (CPS) WERE LOW, SUGGESTING NO SUBSTRATE WAS DISPENSED. CCC INSTRUCTED THE CUSTOMER TO CHECK THE SUBSTRATE TUBING LEADING FROM THE SUBSTRATE RESERVOIR AND THE CUSTOMER STATED IT WAS KINKED AND TWISTED. THE CUSTOMER STATED THAT THE OPERATORS HAD BEEN UNSCREWING THE TUBING FROM THE SUBSTRATE PUMP TO EMPTY THE RESERVOIR AND THE TUBING COULD HAVE KINKED UPON RE-CONNECTING THE LINE. CCC PROVIDED AN ALTERNATIVE INSTRUCTION AND INSTRUCTED THE CUSTOMER TO PRIME THE LINES. PRECISION TESTING AND QUALITY CONTROLS WERE RUN, RESULTING WITHIN RANGE. THE CAUSE OF THE DISCORDANT GH AND SHBG RESULTS IS A HUMAN FACTORS ISSUE. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT GROWTH HORMONE (GH) AND SHBG (SEX HORMONE-BINDING GLOBULIN) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON AN IMMULITE 2000 XPI INSTRUMENT. AT THE TIME THE PATIENT SAMPLES WERE RUN, MANY SAMPLES PRODUCED INSTRUMENT ERRORS INSTEAD OF RESULTS. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT AFTER TROUBLESHOOTING, RESULTING AS EXPECTED. THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT GH AND SHBG RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308825 IMMULITE 2000 XPI IMMULITE 2000 XPI JJQ SIEMENS HEALTCHCARE DIAGNOSTICS INC IMMULITE 2000 XPI

    Patients

    Seq Age Sex Outcome Treatment
    1