BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSMEX WORK AREA MANAGEMENT SYSTEM

    MDR report key: 5074468 · Received September 14, 2015

    Report

    Report Number
    1000515253-2015-00006
    Event Type
    Malfunction
    Date Received
    September 14, 2015
    Date of Event
    July 15, 2015
    Report Date
    July 15, 2015
    Manufacturer
    SYSMEX AMERICA INCORPORATE
    Product Code
    OUG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    WAM IS A MEDICAL DEVICE DATA SYSTEM (MDDS) THAT RECEIVES DATA FROM SYSMEX HEMATOLOGY ANALYZERS. NO ANALYZER FAILURE WAS IDENTIFIED. WAM APPLIES THE DILUTION FACTOR TO THE SELECTED RUN CHOSEN BY THE OPERATOR. CODING DEFECT 621 APPLIES THE DILUTION FACTOR CORRECTLY TO THE DILUTION RUN AND INCORRECTLY TO THE PREVIOUS RUN. THIS ALTERS THE ORIGINAL RESULTS OF SOME PARAMETERS FROM THE PREVIOUS RUN. THE VALUES FROM THE PREVIOUS RUN AND DILUTION RUNS ARE DISPLAYED SIDE-BY-SIDE ON THE RERUN SCREEN. POST-DILUTION RESULTS MUST BE VALIDATED AND RELEASED MANUALLY BY THE OPERATOR. VALIDATED RESULTS ARE NOT AFFECTED. BECAUSE THE ORIGINAL RESULTS ARE MULTIPLIED BY THE DILUTION FACTOR, A REMOTE POSSIBILITY EXISTS THAT THE OPERATOR MAY INADVERTENTLY REPORT THE ALTERED RESULTS AND RELEASE TO THE CLINICIAN. A PATCH FOR THIS DEFECT WAS DEVELOPED AND IS PENDING RELEASE. A SHORT-TERM CORRECTIVE ACTION IS TO INFORM OPERATORS TO PERFORM DILUTION CALCULATIONS MANUALLY. DILUTIONS ARE PERFORMED AS PART OF INVESTIGATION AND VALIDATION OF RESULTS OF ABNORMAL SAMPLES THEREFORE INITIAL RESULTS ARE KNOWN. DILUTION FACTORS APPLIED SIGNIFICANTLY CHANGE TEST RESULTS (2X, 3X, 5X ETC.) MAKING THE EFFECTS OF THE DEFECT OBVIOUS TO THE USER.

    Description of Event or Problem · 1

    THE USER OF THE WORK AREA MANAGEMENT (WAM) SYSTEM MIDDLEWARE VERSION 5.0 WITH TWO XN-10 AUTOMATED HEMATOLOGY ANALYZERS, REPORTED THAT THE WAM APPLIED THE DILUTION FACTOR TO TEST RESULTS OTHER THE HEMOGLOBIN AND HEMATOCRIT ON THE DILUTED SAMPLE. THE INITIAL ANALYSIS WAS FLAGGED BY THE XN-10 ANALYZER WITH AN ASTERISK, "*," NEXT TO THE RESULTS FOR THE HEMOGLOBIN (HGB), MEAN CELL HEMOGLOBIN (MCH) AND MEAN CORPUSCULAR HEMOGLOBIN CONCENTRATION (MCHC), AN INDICATION OF UNRELIABLE DATA WITH POTENTIAL INTERFERENCE. THE OPERATOR PREPARED A 1:5 DILUTION TO ATTEMPT TO RESOLVE ANY INTERFERENCE AND REPEATED THE ANALYSIS. THE OPERATOR ENTERED THE DILUTION FACTOR INTO THE WAM FOR RUN 2. THE OPERATOR NOTICED THAT THE DILUTION FACTOR WAS APPLIED TO THE ABSOLUTE VALUE OF THE WBC DIFFERENTIAL IN RUN 1 IN ADDITION TO THE DILUTED PARAMETERS IN RUN 2. THE WAM IS INTENDED TO APPLY THE DILUTION FACTOR TO ONLY THE ANALYSIS SELECTED, IN THIS CASE, THE HEMOGLOBIN AND HEMATOCRIT; HOWEVER, BECAUSE OF CODING DEFECT 621, THE DILUTION FACTOR WAS APPLIED TO ABSOLUTE NEUTROPHIL COUNT OF THE INITIAL RUN AND THE ORIGINAL RESULTS WERE ALTERED. THE ERRONEOUS RESULTS WERE NOT REPORTED. NO ADVERSE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605021 SYSMEX WORK AREA MANAGEMENT SYSTEM MIDDLEWARE OUG SYSMEX AMERICA INCORPORATE VERSION 5.0

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other