BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYSMEX XN-10 ANALYZER

    MDR report key: 3593320 · Received January 8, 2014

    Report

    Report Number
    3009711478-2014-00001
    Event Type
    Other
    Date Received
    January 8, 2014
    Date of Event
    December 4, 2013
    Report Date
    December 9, 2013
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    GKZ
    PMA / PMN Number
    K112605
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    USER DID NOT HAVE FLAGGING SET ON THE ANALYZER AND RELIED ON THEIR DATA INNOVATIONS INSTRUMENT MANAGER (NOT A SYSMEX DISTRIBUTION PRODUCT) AS MIDDLEWARE TO ALERT THE OPERATOR TO ABNORMALITIES; AN ALERT WAS NOT PRESENT. THE HGB VALUE WAS ACCOMPANIED BY A (-) MARK, WHICH INDICATES THE HGB VALUE WAS BELOW THE LOWER LIMITS OF THEIR REFERENCE RANGE. THE USER IS RESPONSIBLE FOR SETTINGS THAT WOULD PROPERLY IDENTIFY SAMPLE ABNORMALITIES FOR FURTHER REVIEW PRIOR TO REPORTING. FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO INSPECT ANALYZERS FOR PERFORMANCE ISSUES AND FOUND ANALYZERS TO BE FUNCTIONING WITHIN MANUFACTURER'S SPECIFICATIONS. THE OPERATOR WAS NOT AWARE OF SAMPLE VOLUME REQUIREMENTS FOR AUTO-MODE ANALYSIS. SPURIOUSLY LOW HGB, AS WELL AS ALL THE OTHER LOW PARAMETER RESULTS WAS DUE TO A SHORT SAMPLING OF THE SPECIMEN. THE USER DID NOT NOTE THE SHORT SPECIEM UNTIL AFTER THE RESULTS HAD BEEN REPORTED TO THE CLINICIAN. THE FSE NOTED THE ANALYZER'S BLOOD AND ASPIRATIONS SENSOR WERE FUNCTIONING. SYSMEX XN-9000 INSTRUCTION FOR USE (IFU), CHAPTER 9 - ANALYZING SAMPLES, EXPLAINS THAT THE INSTRUMENT IS EQUIPPED WITH A BLOOD AND AN ASPIRATION SENSOR. CORRECT RESULTS MAY NOT BE OBTAINED IF THE SAMPLE VOLUME IS INSUFFICIENT. INSUFFICIENT BLOOD VOLUME MAY NOT BE DETECTED IF A SPECIMEN LABEL ON THE TUBE EXTENDS BELOW THE SPECIFIED POSITION TO BLOCK THE BLOOD SENSOR. THE SPECIFIC TUBE INVOLVED WAS NOT AVAILABLE TO RULE OUT LABELS AS A CAUSE FOR DEFECTING THE BLOOD SENSOR. NO ANALYZER MALFUNCTION WAS IDENTIFIED. THE USER PLANS TO IMPLEMENT A WORK AREA MANAGEMENT (WAM) SYSTEM MIDDLEWARE WITH RULES TO HOLD ABNORMAL RESULTS FOR REVIEW IN THE FUTURE.

    Description of Event or Problem · 1

    THE USER OF AN XN-10 AUTOMATED HEMATOLOGY ANALYZERS (SERIAL NUMBERS (B)(4)) REPORTED THAT ON (B)(6) 2013, SAMPLE ID (B)(6) GENERATED A SPURIOUSLY LOW HEMOGLOBIN (HGB) RESULT OF 61 G/L; THE RESULT WAS REPORTED TO A CLINICIAN. SUBSEQUENTLY, THE PT WAS UNNECESSARILY TRANSFUSED BASED ON THE LOW HGB RESULT. THE SAMPLE WAS RERUN USING THE MANUAL MODE WITH AN OPEN TUBE; A NORMAL HGB RESULT OF 155G/L WAS OBTAINED. THE INITIAL ANALYSIS WAS PERFORMED USING THE AUTOMATIC MODE. NO FLAGS WERE GENERATED AND THE ANALYZER JUDGED THE SAMPLE AS "NEGATIVE". AFTER REPORTING THE INITIAL RESULTS, THE OPERATOR NOTICED THE SPECIMEN VOLUME WAS LESS THAN 1.0ML. SAMPLES RUN USING THE AUTOMATIC MODE HAVE A SAMPLE MINIMUM REQUIREMENT OF 1.0ML. THE OPERATOR RERAN THE SAMPLE USING THE MANUAL MODE WITH AN OPE TUBE, WHICH REQUIRES LESS VOLUME AT 300 UL; THIS ENABLES OPERATORS TO ANALYZE THE SAMPLE BY MINIMIZING DEAD VOLUME. ALL PARAMETERS ON THE INITIAL ANALYSIS WERE IMPACTED BY THE SHORT SAMPLE WHEN COMPARED TO REPEAT VALUES. NO KNOWN ADVERSE EFFECT TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14807 SYSMEX XN-10 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ SYSMEX CORPORATION XN-10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other