BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSMEX XE-5000

    MDR report key: 2724880 · Received August 30, 2012

    Report

    Report Number
    1422681-2012-00010
    Event Type
    Death
    Date Received
    August 30, 2012
    Date of Event
    August 1, 2012
    Report Date
    August 1, 2012
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    GKZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE USER FACILITY XE-5000 CONTROLLER SETTING REVEALED THAT THE USER FACILITY CHOSE NOT TO SET FLAG FORMULAS ON THE ANALYZER. FLAG FORMULAS ARE DESIGNED FOR THE USER TO ESTABLISH JUDGMENT LIMITS FOR ABNORMAL BLOOD CONDITIONS. THE ACTUAL XE-5000 DEVICE WAS EVALUATED AT THE USER FACILITY. THE EVALUATION DID NOT REVEAL A ROOT CAUSE FOR THE REPORTED EVENT; HOWEVER, THE USER FACILITY, IN CHOOSING TO NOT SET FLAG FORMULAS FOR THE ANALYZER, THE RESULTS COULD NOT BE FLAGGED IN THE FINAL PRINTED RESULT. THE WORK AREA MANAGEMENT (WAM) SOFTWARE RULE THRESHOLD FOR THE USER FACILITY WAS SET FOR A VALUE LESS THAN 600 X 10^9/L; THEREFORE, THE SYSTEM WOULD NOT HAVE THE CAPABILITY TO CAPTURE A VALUE OVER 600. THERE ARE LIMITATIONS OF IMPEDANCE COUNTING AS NOTED IN THE USER MANUAL. GOOD LABORATORY PRACTICE WOULD INCLUDE UTILIZING FLAG FORMULAS IN CONJUNCTION WITH WAM RULES. THE ANALYZER AND WAM FUNCTIONED AS DESIGNED. BURN PTS WITH GREATER THAN 20% OF THE BODY AFFECTED MAY EXPERIENCE MORPHOLOGIC RBC CHANGES INCLUDING GLOBULAR FRAGMENTATION, BUDDING AND MICROSPHERES. OSMOTIC FRAGILITY IS INCREASED.

    Description of Event or Problem · 1

    THE USER FACILITY OBSERVED A FALSE HIGH PLATELET COUNT (PLT) ON A BURN PATIENT IN THE EMERGENCY ROOM. A COMPLETE BLOOD COUNT (CBC) AND NUCLEATED RED BLOOD CELLS (NRBC) WERE ANALYZED ON AN XE-5000 AUTOMATED HEMATOLOGY ANALYZER AT 13:11 IN THE AUTOMATED MODE. THE SAMPLE WAS JUDGED "NEGATIVE" WITH NO FLAGS. WORK AREA MANAGER (WAM) MIDDLEWARE HELD THE REPORT AS THE PLTS RESULTS WERE A CRITICAL HIGH VALUE. THE RESULTS WERE RELEASED TO THE EMERGENCY ROOM WITH A VALUE OF PLT=770. THE OPERATOR OF THE DEVICE WAS UNAWARE AT THE TIME THAT THE PT WAS BEING TREATED AS A BURN PT. THE USER INDICATED THAT AT AN UNSPECIFIED TIME, A PHASE MICROSCOPY PERFORMED WITH PLT=105. THE ORIGINAL SAMPLE WAS REPEATED, USING TWO ADDITIONAL CHANNELS FOR A CBC+ DIFFERENTIAL (DIFF) +NRBC+RETICULOCYTE AT 15:24 WITH A REPORTED PLT=751. THE SAMPLE RESULTS WERE IDENTIFIED AS "POSITIVE" WITH MORPHOLOGY AND COUNT ERRORS. A SECOND BLOOD SAMPLE WAS DRAWN IN THE INTENSIVE CARE BURN UNIT. THE SAMPLE WAS ANALYZED AT 17:10 FOR CBC AND DIFF +NRBC IN THE AUTOMATED MODE-PLT=611, "POSITIVE" WITH A COUNT ERROR. THE PT WAS REMOVED FROM LIFE SUPPORT AT AN UNSPECIFIED TIME AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSMEX XE-5000 AUTOMATED HEMATOLOGY ANALYZER GKZ SYSMEX CORPORATION 063-7591-7

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death WAM 3000 V.3.0, S/N: (B)(4), MANUFACTURED BY| WORK AREA MANAGEMENT (WAM) SOFTWARE,| SYSMEX, INC.