BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 XPI

    MDR report key: 3808902 · Received May 13, 2014

    Report

    Report Number
    2247117-2014-00026
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 16, 2014
    Manufacturer
    SIEMENS HEALTCHCARE DIAGNOSTICS INC
    Product Code
    JJQ
    PMA / PMN Number
    P010053/S007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE CSE DID NOT FIND AN INSTRUMENT MALFUNCTION. THE CSE CLEANED THE WASH STATION MANIFOLD AND RAN A WATER TEST WHICH RESULTED AS EXPECTED. QUALITY CONTROLS WERE RUN, RESULTING WITHIN RANGE. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED INSULIN RESULT IS UNKNOWN, AS THE SAMPLE RESULTED AS EXPECTED WHEN REPEATED ON THE SAME INSTRUMENT. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY ELEVATED INSULIN RESULT WAS OBTAINED ON ONE PEDIATRIC PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED TWICE ON THE SAME INSTRUMENT, RESULTING LOWER. IT IS UNKNOWN IF THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED INSULIN RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286200 IMMULITE 2000 XPI IMMULITE 2000 XPI JJQ SIEMENS HEALTCHCARE DIAGNOSTICS INC IMMULITE 2000 XPI

    Patients

    Seq Age Sex Outcome Treatment
    1