BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSMEX WORK AREA MANAGEMENT SYSTEM

    MDR report key: 5399846 · Received January 29, 2016

    Report

    Report Number
    1000515253-2016-00001
    Event Type
    Malfunction
    Date Received
    January 29, 2016
    Date of Event
    December 15, 2015
    Report Date
    December 15, 2015
    Manufacturer
    SYSMEX AMERICA INC.
    Product Code
    OUG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 A SYSMEX WORK AREA MANAGEMENT (WAM) SYSTEM MIDDLEWARE REPORTED THAT WHILE PERFORMING DILUTION RUNS, USING WAM, THE USER ENTERED A DILUTION FACTOR AND RAN THE SAMPLE BUT WAM DID NOT CORRECTLY PERFORM THE CALCULATION(S). NO SCREENSHOTS OR RESULTS WERE SUBMITTED FOR EVALUATION. SOFTWARE TECHNICAL SPECIALIST (STS) EXPLAINED TO USER THAT THE ISSUE IS DEFECT 621 AND EMAILED A PRODUCT NOTICE 62-1292 - SYSMEX WAM V5.X RERUN SCREEN - DILUTION CALCULATION CORRECTION, TO LABORATORY REPRESENTATIVE. THE STS INSTRUCTED USER NOT TO RUN DILUTIONS USING WAM. PER STS THE USER WILL MANUALLY DILUTE, PERFORM CALCULATIONS AND MANUALLY ENTER THE RESULTS INTO WAM. NO ERRONEOUS RESULTS WERE REPORTED WERE REPORTED OUT OF THE LABORATORY. NO ADVERSE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57606 SYSMEX WORK AREA MANAGEMENT SYSTEM MIDDLEWARE OUG SYSMEX AMERICA INC. VERSION 5.0

    Patients

    Seq Age Sex Outcome Treatment
    1 Other