BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSMEX WORK AREA MANAGEMENT SYSTEM

    MDR report key: 9841725 · Received March 17, 2020

    Report

    Report Number
    1000515253-2020-00012
    Event Type
    Injury
    Date Received
    March 17, 2020
    Date of Event
    February 5, 2020
    Report Date
    March 17, 2020
    Manufacturer
    SYSMEX AMERICA INC.
    Product Code
    OUG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN PROCESSING BODY FLUIDS, THE OPERATOR SELECTS THE COLOR FROM A LIST OF OPTIONS DEFINED BY THE SITE IN THE "COLOR CSF" FIELD. THESE OPTIONS INCLUDED AMBER, BROWN, CONDITION OF SPECIMEN MAKES CELL COUNT IMPOSSIBLE, COLORLESS, OTHER, PINK, RED AND XANTHOCHROMIC. THE OPERATOR ALSO SELECTED A RESULT FOR THE "XANTHOCHROMIC" FIELD. THE OPTIONS INCLUDED ABSENT, CONDITION OF SPECIMEN MAKES CELL COUNT IMPOSSIBLE OR PRESENT. IN THIS CASE, THE OPERATOR SELECTED "XANTHOCHROMIC" FOR THE "COLOR CSF" FIELD BUT SELECTED "ABSENT" FOR THE "XANTHOCHROMIC" FIELD. SYSMEX WAM IS A HEMATOLOGY INFORMATION MANAGEMENT SYSTEM THAT OFFERS A COMPREHENSIVE ANALYZER AND RESULT MANAGEMENT TOOL. SYSMEX WAM CONSOLIDATES DATA FROM MULTIPLE ANALYZERS, PERFORMS COMPLEX RULES-BASED FUNCTIONS, AIDS THE TECHNOLOGIST IN RESULTS REVIEW/DATA INTERPRETATION, AND THEN SENDS THIS INFORMATION TO THE LABORATORY INFORMATION SYSTEM (LIS). HOWEVER, IT IS THE USER'S RESPONSIBILITY TO TEST ALL WORKFLOW AND RULES PRIOR TO IMPLEMENTATION. USER ERROR CAUSED THIS EVENT. WAM PERFORMED AS DESIGNED.

    Description of Event or Problem · 1

    AN OPERATOR OF WORK AREA MANAGER (WAM) SYSTEM MIDDLEWARE VERSION 5.02 SELECTED "XANTHOCHROMIA" FROM THE OPTIONS FOR THE "COLOR CSF" FIELD ON A CEREBRAL SPINAL FLUID (CSF). THE OPERATOR ALSO INCORRECTLY SELECTED "ABSENT" FROM OPTIONS FOR THE "XANTHOCHROMIA" FIELD. ERRONEOUS RESULTS WERE REPORTED. A CORRECTED REPORT WAS ISSUED CHANGING THE XANTHOCHROMIA RESULT TO "PRESENT". THE OPERATOR ALLEGED A DELAY IN MULTIPLE TREATMENTS DUE TO THE ERRONEOUS RESULTS BEING RELEASED TO THE MEDICAL TEAM. THE TREATMENTS INCLUDED NIMODIPINE INITIATION, PLACEMENT OF AN EXTERNAL VENTRICULAR DRAIN, AND ADMISSION TO THE NEURO INTENSIVE CARE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307947 SYSMEX WORK AREA MANAGEMENT SYSTEM MIDDLEWARE OUG SYSMEX AMERICA INC. WAM VERSION 5.0.2

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other