BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYSMEX XE-5000 AUTOMATED HEMATOLOGY ANALYZER

    MDR report key: 2560165 · Received May 20, 2010

    Report

    Report Number
    1422681-2010-00003
    Event Type
    Other
    Date Received
    May 20, 2010
    Date of Event
    July 8, 2009
    Report Date
    May 20, 2010
    Manufacturer
    SYSMEX CORP
    Product Code
    GKZ
    PMA / PMN Number
    K071967
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE TWO XE-5000 AUTOMATED HEMATOLOGY ANALYZERS ((B)(4)) INVOLVED IN THE EVENT ARE INTERFACED WITH ONE SYSMEX-WAM VERSION 3.0 MIDDLEWARE ((B)(4)). THE SYSMEX-WAM IS A WORK WARE MANAGEMENT MIDDLEWARE SYSTEM THAT TRANSMITS PT RESULT DATA FROM THE ANALYZERS TO USER'S LABORATORY INFORMATION SYSTEM (LIS). INVESTIGATION INTO THE ISSUE DETERMINED THAT THE IG% AND IG# VALUES HAD BEEN CORRECTLY GENERATED BY THE XE-5000 ANALYZERS. HOWEVER, REVIEW OF THE CONFIGURATION RULES SETTINGS FOR THE IG PARAMETERS WITHIN THE WAM MIDDLEWARE PRODUCT DETERMINED THAT THERE WAS A MULTIPLIER OF 0.01 INSTEAD OF 0.1, WHICH RESULTED IN ERRONEOUS (FALSELY LOW) IG RESULTS SENT TO THE USER'S LIS, WHICH WERE SUBSEQUENTLY REPORTED OUT. REVIEW OF THE USER'S WAM SUPPORT FILE INDICATED THAT THE CORRECT IG# AND IG% RULES SETTINGS HAD BEEN PRESENT AT "GO LIVE" AND WERE SIGNED OFF BY THE USER ON (B)(6) 2009. HOWEVER, THE IG# AND IG% RULES SETTINGS WERE CHANGED BY A SYSMEX IMPLEMENTATION SUPPORT SPECIALIST ON (B)(4) 2009. THE ROOT CAUSE FOR THE PROBLEM OF ERRONEOUS IG% AND IG# VALUES WAS A RULES SETTING CHANGE MADE IN THE USER'S PRODUCTION ENVIRONMENT ON (B)(4) 2009. THE DOCUMENTATION DID NOT INDICATE WHY THE CHANGE HAD BEEN MADE, OR WHO REQUESTED THE CHANGE. ADDITIONALLY THERE WAS NO EVIDENCE OF TESTING, VALIDATION, OR APPROVAL TO IMPLEMENT THE RULES SETTING CHANGE. NO MALFUNCTION OF THE MEDICAL DEVICE (XE-5000 ANALYZERS), OR THE WAM MIDDLEWARE PRODUCT WAS IDENTIFIED. A CORRECTIVE ACTION HAS BEEN INITIATED TO PREVENT RECURRENCE.

    Description of Event or Problem · 1

    THE USER OF AN XE-5000 AUTOMATED HEMATOLOGY ANALYZER (SERIAL NUMBERS (B)(4)) IN CONJUNCTION WITH SYSMEX-WAM VERSION 3.0 MIDDLEWARE (SERIAL NUMBER (B)(4)) AND (B)(6); INDICATED (B)(6) 2010, THAT THEY HAD DISCOVERED AN ISSUE WITH THE REPORTING OR IMMATURE GRANULOCYTE (PERCENTAGE AND ABSOLUTE) RESULTS. THE IMMATURE GRANULOCYTE PERCENTAGE (IG%) AND ABSOLUTE COUNT (IG#) WERE CORRECTLY GENERATED FROM THE XE-5000 ANALYZERS; HOWEVER, ONCE REPORTED FROM THE WAM MIDDLEWARE, THE RESULTS WERE OFF BY A FACTOR OF TEN. FOR EXAMPLE, THE XE-5000 ANALYZER GENERATED A RESULT OF (B)(4) FOR IG%, AND THE WAM DISPLAYED A RESULT OF 3.5%, WHICH WAS THEN TRANSMITTED TO (B)(6). TROUBLESHOOTING PERFORMED BY THE USER AND SYSMEX ON (B)(6) 2010, DETERMINED THAT THE ISSUE HAD STARTED ON (B)(6) 2009. WHEN REPORTED, THE ISSUE WAS IMMEDIATELY CORRECTED, VALIDATED AND MOVED TO THE CUSTOMER'S WAM MIDDLEWARE PRODUCTION ENVIRONMENT ON (B)(6) 2010. A REVIEW OF ALL PT REPORTS GENERATED FOR THE TIME PERIOD OF (B)(6) 2009 TO (B)(6) 2010 INDICATED THAT A TOTAL OF (B)(4) PT REPORTS WERE AFFECTED, WHICH INVOLVED A TOTAL OF (B)(4)INDIVIDUAL PTS. TO DATE, THERE IS NO KNOWN IMPACT TO THE TREATMENT OF ANY OF THESE PTS. THE PATHOLOGIST AND MEDICAL DIRECTOR AT THE USER FACILITY HAS INDICATED THAT NEONATAL, PEDIATRIC, AND CANCER PTS ARE THE PT POPULATIONS ROUTINELY EVALUATED BY THEIR HOSPITAL. THE PATHOLOGIST'S OPINION IS THAT ADVERSE PT IMPACT WAS NOT LIKELY FOR THE NEONATAL AND PEDIATRIC POPULATIONS, BASED ON THE LABORATORY'S PROCEDURES FOR MANUAL DIFFERENTIAL REVIEW. THE PATHOLOGIST BELIEVES THERE MAY HAVE BEEN A POTENTIAL IMPACT TO THE CANCER PT POPULATION; HOWEVER, BECAUSE DIFFERENTIALS ARE USED TO MONITOR THE PT'S RESPONSE TO CHEMOTHERAPY AND THERE MAY BE A DELAY IN TREATMENT, AS A RESULT OF AN INCORRECT IG% REPORTED. OVERALL, THE PATHOLOGIST BELIEVES THAT IMMATURE GRANULOCYTES ARE NOT CLINICALLY SIGNIFICANT IN MOST OF THEIR SPECIFIC PT POPULATIONS. SYSMEX CONTINUES TO WORK CLOSELY WITH THE SITE TO COLLECT INFORMATION RELATED TO PT IMPACT AND, AT THE TIME OF THIS SUBMISSION, NO PT HARM HAS BEEN IDENTIFIED WITH APPROXIMATELY 50% OF THE RESULTS REVIEWS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSMEX XE-5000 AUTOMATED HEMATOLOGY ANALYZER XE-5000 GKZ SYSMEX CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other