BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSMEX XS-1000I ANALYZER

    MDR report key: 3368450 · Received September 13, 2013

    Report

    Report Number
    3009711478-2013-00010
    Event Type
    Death
    Date Received
    September 13, 2013
    Date of Event
    August 7, 2013
    Report Date
    September 9, 2013
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    GKZ
    PMA / PMN Number
    K060656
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS (B)(6) AND IS SERVICED BY (B)(6). THE CLIENT DID NOT HAVE A E-CHECK COMMERCIAL CONTROLS TO ANALYZE ON THE DAY OF THE EVENT, BUT RAN A PT SAMPLE FROM THE PREVIOUS DAY, AND ALL WERE WITHIN THE ACCEPTABLE RANGE. THE DAY AFTER THE EVENT, E-CHECK CONTROLS WERE USED RESULTS WERE WITHIN RANGE. A (B)(6) FIELD SERVICE REPRESENTATIVE (FSR) VISITED THE SITE AND PERFORMED A PRECISION CHECK AND THE PRECISION WAS WITHIN ACCEPTABLE RANGE FOR ALL PARAMETERS. THE SAMPLE PATH FOR CONTROLS AND SAMPLES IS THE SAME. THE FSR SUSPECTED A POSSIBLE CLOG DURING ASPIRATION OF THIS SPECIFIC SAMPLE, AND DISCOVERED THE SAMPLE DETECTION SENSOR WAS TURNED OFF. THE MODE OF ANALYSIS (AUTOMATED OR MANUAL) WAS NOT PROVIDED. MANUAL ANALYSIS REQUIRES THE OPERATOR TO MIX AND ASSURE COMPLETE ASPIRATION OF THE SAMPLE. THE FSR CLEANED THE SAMPLE PATH FOR THE HGB CHANNEL, INCLUDING CLEANING/VERIFICATION OF TUBING, CHAMBERS AND VALVES, AND VERIFIED DILUTION. A FAILURE WAS NOT FOUND, AND THE ANALYZER WILL BE MONITORED BY THE USER.

    Description of Event or Problem · 1

    THE USER OF A SYSMEX XS-1000I ANALYZER, SERIAL NUMBER (B)(4), REPORTED TO (B)(6), THAT THE OPERATOR REPORTED AN INCORRECT, LOW HEMOGLOBIN RESULT FOR (B)(6) MALE WHO WAS ADMITTED TO THE HOSPITAL FOR A SURGERY OF "COLICISTITE B VIDEO" ON (B)(6) 2013. THE SURGERY WAS PERFORMED SUCCESSFULLY, AND THE PT WAS DISCHARGED. ON THIS DAY, HE FELT DIZZY AND FELL. AT THAT MOMENT, THE DOCTOR MADE THE REQUEST OF A COMPLETE BLOOD COUNT (CBC) THE RED BLOOD CELL (RBC) DATA WAS VERY LOW, INCLUDING A HEMOGLOBIN (HGB)=4 MG/DL. THESE LOW RESULTS WERE RELAYED BY PHONE TO THE SAMPLE BEING REPEATED. DUE TO THE CLINICAL PICTURE OF THE PT, THE DOCTOR DECIDED TO PERFORM A MICROSURGERY TO VERIFY IF THERE WAS SOME INTERNAL BLEEDING, WHICH WAS NOT APPARENT. AFTER THIS PROCEDURE, THE PT DIED AND AN AUTOPSY SHOWED DEATH DUE TO PULMONARY THROMBOEMBOLISM. THE SAMPLE WAS REPEATED AND THE RBC RESULTS WERE "NORMAL." NO DATA WAS SUPPLIED WITH THIS REPORT TO DETERMINE WHETHER FLAGS OR ERRORS WERE IDENTIFIED ON THE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461257 SYSMEX XS-1000I ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ SYSMEX CORPORATION XS-1000I

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other