BEUDAMED
    FDA Adverse Event Death Summary report: N

    XN-10

    MDR report key: 6255192 · Received January 16, 2017

    Report

    Report Number
    1000515253-2017-00003
    Event Type
    Death
    Date Received
    January 16, 2017
    Date of Event
    December 28, 2016
    Report Date
    January 16, 2017
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    GKZ
    PMA / PMN Number
    K112605
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSMEX XN-2000 INSTRUCTIONS FOR USE - CHAPTER 9, ANALYZING SAMPLES: NOTES: "THE INSTRUMENT IS EQUIPPED WITH A BLOOD ASPIRATION SENSOR. HOWEVER, THERE IS A POSSIBILITY THAT CORRECT RESULTS MAY NOT BE OBTAINED IF THE SAMPLE VOLUME IS LOW AND THE SENSOR COULD NOT DETECT A SHORT SAMPLE OR SAMPLE NOT ASP ERROR. IF YOU KNOW IN ADVANCE THAT THE BLOOD SAMPLE HAS A VERY LOW HGB, DISABLE THE BLOOD ASPIRATION SENSOR." THE USER CONTACTED SYSMEX THE NEXT DAY AND WAS ADVISED TO TURN OFF THE BLOOD SENSOR AND RE-ANALYZE THE SAMPLE. A HGB RESULT OF 2.9 G/DL WAS GENERATED. IT WAS DETERMINED THAT THE INSTRUMENT PERFORMED AS DESIGNED.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED TO THE ER WITH WEAKNESS, JAUNDICED AND SHORTNESS OF BREATH. AT 15:28, THE PATIENT'S SAMPLE, WHICH WAS DESCRIBED AS APPEARING VERY DILUTED, WAS ANALYZED. "SHORT SAMPLE ERRORS" AND "BLOOD ASPIRATION ERRORS" WERE GENERATED AND RESULTS WERE DISPLAYED AS DASHES (---) INDICATING ENUMERATION WAS NOT POSSIBLE. THE SAMPLE WAS REPEATED, WITH THE SAME RESULTS GENERATED. DURING THE NEXT 5 HOURS, MULTIPLE SAMPLES WERE RECOLLECTED FROM THIS PATIENT AS VENOUS DRAW AND IV DRAW, AND THE SAME ERRORS OCCURRED WITH NO RESULTS AVAILABLE. THE USER DID NOT CALL SYSMEX FOR ADDITIONAL ADVICE IN TROUBLESHOOTING THIS ISSUE. THE USER DID NOT SEND THE SAMPLES TO ANOTHER FACILITY FOR VERIFICATION. IT IS UNKNOWN IF THE FACILITY HAD AN ADDITIONAL SYSTEM FOR REPORTING HGB RESULTS. AN RBC TRANSFUSION WAS ADMINISTERED STARTING AT 20:43, THE PATIENT CODED AT 20:55 AND THE TRANSFUSION WAS STOPPED. USER CONFIRMED THAT THE PATIENT EXPIRED AT ABOUT 20:55. USER ALLEGED THAT THE DELAY IN LAB RESULTS CONTRIBUTED TO THE DEATH OF THE PATIENT. CAUSE OF DEATH WAS REPORTED TO BE SEVERE ANEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36044 XN-10 AUTOMATED HEMATOLOGY ANALYZER GKZ SYSMEX CORPORATION XN-10

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death