BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSMEX WORK AREA MANAGER (WAM)

    MDR report key: 2512883 · Received March 28, 2012

    Report

    Report Number
    1422681-2012-00005
    Event Type
    Malfunction
    Date Received
    March 28, 2012
    Date of Event
    February 25, 2012
    Report Date
    February 27, 2012
    Manufacturer
    SYSMEX AMERICA, INC.
    Product Code
    OUG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSMEX WAM SOFTWARE APPLICATION IS AN INFORMATION MANAGEMENT TOOL THAT PROVIDES COMPREHENSIVE MANAGEMENT OF HEMATOLOGY INSTRUMENT TEST ORDER INFO AND RESULTS DATA. THIS SOFTWARE IS CONSIDERED A CLASS I MEDICAL DEVICE DATA SYSTEM (MDDS). THE WAM CONSOLIDATES RESULTS DATA FROM MULTIPLE INSTRUMENTS, EVALUATES RESULTS USING TEST ORDER RULES CRITERIA AND COMMUNICATES THIS INFO TO THE LIS. THE RULES ARE CRITICAL TO THE INTENDED USE OF THIS APPLICATION. RESULTS FROM THE INSTRUMENT AND WAM WERE CORRECTLY DISPLAYED, BUT THE DATABASE TABLE FOR THE RULES WAS CORRUPTED. THE ROOT CAUSE MAY BE ASSOCIATED WITH A POSSIBLE DATABASE CORRUPTION AFTER A DISK IN THE RAID ARRAY WAS IMPACTED BY A BATTERY FAILURE IN (B)(6) 2012. THE INTEGRITY OF A SECTOR ON THE HARD DISK USED BY ORACLE TO READ/WRITE DATA FROM THE RULES TABLE MAY HAVE BEEN COMPROMISED. THE FACILITY WAS AWARE OF NUMEROUS COMMUNICATION ISSUES INCLUDING SERVER MAINTENANCE, LASC RESTARTS, BATCH JOBS NOT RUNNING, ETC, WITHIN THE PAST FEW DAYS, BUT THE RULES NOT TRIGGERING TO REQUIRE FURTHER REVIEW AND VALIDATION BY THE USER PRIOR TO RELEASE OF THE RESULTS, OR TO ALERT THE USER TO REPORT CRITICAL VALUES TO THE PHYSICIAN WAS NOT IMMEDIATELY APPARENT. THE ISSUE WAS RECOGNIZED AND THE SAMPLES WERE MANAGED APPROPRIATELY BY THE LAB WITHIN 2-3 HOURS OF THE ORIGINAL SAMPLE ANALYSIS (PHYSICIAN CALLED, RESULTS VERIFIED, REPORT AMENDED). THE INTENDED USE OF THE WAM AND HEMATOLOGY ANALYZERS IS FOR IN VITRO DIAGNOSTIC USE IN SCREENING PT POPULATIONS FOUND IN CLINICAL LABORATORIES. RESULTS THAT WERE INCONSISTENT WITH THE PT'S OTHER CLINICAL SIGNS AND SYMPTOMS REQUIRE VERIFICATION PRIOR TO CLINICAL DECISION MAKING.

    Description of Event or Problem · 1

    THE USER OF THE WORK AREA MANAGER (WAM) V 3.0 USED IN CONJUNCTION WITH THEIR SYSMEX HEMATOLOGY ANALYZERS REPORTED THAT RESULTS WERE AUTO VALIDATING THAT SHOULD HAVE BEEN HELD FOR ADDITIONAL REVIEW. FOUR SAMPLE RESULTS WERE IDENTIFIED HAS HAVING AUTO-VALIDATED, AND ONE REQUIRED A CORRECTED REPORT. THREE OF THE FOUR AUTO-VALIDATED RESULTS HAD CRITICAL VALUES. THE USER REPORTED SEVERAL COMMUNICATION ISSUES BEGINNING WITH THEIR LAB INFORMATION SYSTEM (LIS), MEDITECH, COMMUNICATING WITH WAM, BUT DATA WAS NOT TRANSFERRING BETWEEN THE INSTRUMENT, LINE CONTROLLER (LASC) AND WAM, LATER, THE AUTO-VALIDATION CONCERN WAS ESCALATED TO SYSMEX WAM TECHNICAL ASSISTANCE CENTER WHO DETERMINED THAT THE RULES ENGINE FILE COULD NOT BE VIEWED DUE TO AN ERROR MESSAGE "FAILED TO FIND GLOBAL PROC LIBRARY MODULE CA_VAL_FL_CHG". THE RULES FILE WAS FOUND TO BE CORRUPT, CAUSING RULES NOT TO TRIGGER TO HOLD THE RESULTS OR ALERT THE USER OF CRITICAL VALUES. THE CORRUPTED RULES TABLE WAS RECONSTRUCTED BY COPYING THE RULES IN THE TEST ENVIRONMENT TO THE PRODUCTION ENVIRONMENT TO RESOLVE THE ISSUE. THERE WAS NO ALLEGATION OF DELAY IN TREATMENT DUE TO THE AUTO-VALIDATION OF CRITICAL RESULTS, NOR ANY ADVERSE IMPACT AS A RESULT OF THE CORRECTED REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSMEX WORK AREA MANAGER (WAM) MEDICAL DEVICE DATA SYSTEM OUG SYSMEX AMERICA, INC. WAM 3.0

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other HEMATOLOGY SYSTEM TRANSPORT (HST) CONFIGURATION| (B)(4) SLIDE PREPARER IN AN| (B)(4) ANALYZERS AND