BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSMEX WORK AREA MANAGER SYSTEM

    MDR report key: 5069583 · Received September 10, 2015

    Report

    Report Number
    1000515253-2015-00005
    Event Type
    Malfunction
    Date Received
    September 10, 2015
    Date of Event
    August 10, 2015
    Report Date
    August 12, 2015
    Manufacturer
    SYSMEX AMERICA INC.
    Product Code
    OUG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF THIS REPORT FROM 09/10/2015 TO 08/12/2015.

    Additional Manufacturer Narrative · 1

    WAM IS A MEDICAL DEVICE DATA SYSTEM THAT RECEIVES DATA FROM SYSMEX HEMATOLOGY ANALYZERS. THERE IS NO FAILURE OF THE ANALYZER. 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. RESULTS POST DILUTION MUST BE MANUALLY VALIDATED AND RELEASED BY THE OPERATOR. VALIDATED RESULTS ARE NOT AFFECTED BY THIS DEFECT. BECAUSE THE ORIGINAL RESULTS ARE MULTIPLIED BY THE DILUTION FACTOR THERE IS A REMOTE POSSIBILITY THE OPERATOR MAY INADVERTENTLY RELEASE RESULTS 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 SYSMEX WORK AREA MANAGEMENT (WAM) MIDDLEWARE (SERIAL NUMBER (B)(4)) VERSION 5.0 REPORTED TO THE WAM TECHNICAL ASSISTANCE CENTER (TAC) ON (B)(6) 2015 THAT A DILUTION FACTOR WAS ADDED TO PARAMETERS FROM A PREVIOUS ANALYSIS INCORRECTLY. THE SAMPLE ID (SID) INVOLVED WAS (B)(6) FROM AN (B)(6) MALE PATIENT. THE CORRECT RESULTS WERE RECEIVED FROM THE XN-10 HEMATOLOGY ANALYZER. ON WAM THE OPERATOR PERFORMED INITIAL ANALYSIS (RUN 1). THE PLATELET (PLT) VALUE GENERATED BY THE ANALYZER WAS 192 X 10^9/L. SEVERAL OPERATOR ALERTS WERE TRIGGERED INCLUDING HEMOGLOBIN (HGB) ASTERISK FLAG: PERFORM A SPUN HEMATOCRIT (HCT); PLT ASTERISK FLAG: SCAN SLIDE TO CONFIRM; PLT CLUMPS: RERUN PLT-F. CHECK SAMPLE FOR CLOT. PERFORM SLIDE REVIEW AND TURBIDITY/HGB INTERFERENCE: PREWARM THE SAMPLE AND ADD RERUN. THE OPERATOR PERFORMED A 1:3 DILUTION AND REANALYZED THE SAMPLE (RUN 2) FOR THE PLT PARAMETER. THE PLT VALUE GENERATED BY THE ANALYZER WAS 65 X 10^9/L. THE OPERATOR SELECTED RUN 2 AND APPLIED A CALCULATION OF 3.000 WHICH GENERATED A PLT VALUE OF 195 X 10^9/L. THE OPERATOR NOTICED WAM ADDED THE CALCULATION OF 3.000 TO THE INITIAL ANALYSIS (RUN 1) VALUES OF WHITE BLOOD CELL (WBC), RED BLOOD CELL (RBC), HEMOGLOBIN (HGB) AND HEMATOCRIT (HCT) PARAMETERS. THE MODIFICATION OF VALUES BY WAM WAS OBVIOUS TO THE OPERATOR. THE OPERATOR QUESTIONED THE RESULTS GENERATED BY WAM AND PERFORMED REPEAT ANALYSIS (RUN 3) ON THE 1:3 DILUTION FOR ALL PARAMETERS AND APPLIED A CALCULATION OF 3.000 IN WAM. THE OPERATOR REVIEWED THE RERUN SCREEN PRIOR TO VALIDATING THE PLATELET RESULT AND NOTICED THE INCORRECT APPLICATION OF THE DILUTION FACTOR. NO ERRONEOUS RESULTS WERE REPORTED. THERE WAS NO ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600419 SYSMEX WORK AREA MANAGER SYSTEM MIDDLEWARE OUG SYSMEX AMERICA INC. V 5.0

    Patients

    Seq Age Sex Outcome Treatment
    1 8 DA Other