BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSMEX XS-1000I ANALYZER

    MDR report key: 3034726 · Received February 11, 2013

    Report

    Report Number
    1422681-2013-00004
    Event Type
    Death
    Date Received
    February 11, 2013
    Date of Event
    December 19, 2012
    Report Date
    January 11, 2013
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    GKZ
    PMA / PMN Number
    K060656
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS INCIDENT SHOWS THAT BOTH THE SYSMEX XS-1000I ANALYZER AND THE WAM MIDDLEWARE WORKED AS INTENDED. THE CRITICALLY LOW RESULTS FOR RBC PARAMETERS WERE ACCURATE AND THE WAM GAVE A SPECIFIC OPERATOR ALERT THAT INSTRUCTED THE USER TO NOTIFY CLINICAL PERSONNEL OF THE VALUES AND TO CHECK THE SAMPLE. THE USER FAILED TO ENTER THE INFO INTO THE CRITICAL CALL BOX CORRECTLY. THE SUNQUEST LIS REQUIRES ANY FREE TEXT COMMENTS TO BE PRECEDED BY A SEMICOLON SO THAT THE COMMENT WILL BE REPORTED. THE USER ALSO DID NOT RUN A PENDING LOG BEFORE LEAVING FOR THE DAY TO ENSURE THAT THE RESULT WAS POSTED TO THE FILE. THE SYSMEX PRODUCTS WERE INVOLVED, BUT DID NOT CAUSE THE EVENT. THIS ISSUE IS REPORTED BECAUSE TREATMENT WAS DELAYED AND THE PT ULTIMATELY DIED.

    Description of Event or Problem · 1

    THE USER OF A SYSMEX XS-1000I S/N (B)(4) AND THE WORK AREA MGMT SYSTEM MIDDLEWARE S/N (B)(4) REPORTED TO A TECHNICAL INTEGRATION SPECIALIST ON (B)(6) 2013 AN INSTANCE IN WHICH CRITICALLY LOW RBC, HEMOGLOBIN (HGB) AND HEMATOCRIT (HCT) VALUES WERE NOT REPORTED TO THE PHYSICIAN IN A TIMELY MANNER. THE PT'S CONDITION WAS SUCH THAT HOSPITALIZATION WAS REQUIRED IMMEDIATELY. THE TECH GAVE THE PHYSICIAN A COPY OF THE INSTRUMENT PRINTOUT, DEMONSTRATING THE LOW VALUES, BUT DID NOT ENTER THE PROPER CODING IN A CRITICAL CALL BOX IN THE WAM FOR THE RESULTS TO BE ACCEPTED BY THE USER'S LAB INFO SYS. THE TECH ENTERED THE RESULTS IN WAM AND THEN WENT HOME FOR THE DAY WITHOUT CHECKING THE LIS PENDING LOG. THE PT WENT HOME AND PRESENTED AT A HOSPITAL WITHIN THE HEALTH-CARE SYS TWO DAYS LATER. HE RECEIVED A TRANSFUSION, BUT ULTIMATELY DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60740 SYSMEX XS-1000I ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ SYSMEX CORPORATION XS-1000I

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention