BEUDAMED
    FDA Adverse Event Death Summary report: N

    DXI 9000

    MDR report key: 21527109 · Received March 5, 2025

    Report

    Report Number
    2122870-2025-00072
    Event Type
    Death
    Date Received
    March 5, 2025
    Date of Event
    February 6, 2025
    Report Date
    March 17, 2025
    Manufacturer
    BECKMAN COULTER, INC
    Product Code
    JJE
    UDI-DI
    15099590732103
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: THE FULL PATIENT IDENTIFIER IS (B)(4). A2, A3, A4 AND A5: THE CUSTOMER DID NOT SUPPLY PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX, WEIGHT, ETHNICITY OR RACE. H3 AND H6: THE BECKMAN COULTER R&D TEAM HAS IMPLEMENTED A TEMPORARY COUNTERMEASURE WHICH HAS BEEN VERIFIED BY THE ONSITE FIELD SERVICE ENGINEER TO ADDRESS THE ISSUE. THE STEPS FOR THIS SHORT-TERM SOLUTION ARE AS FOLLOWS: NAVIGATE TO SYSTEM CONFIGURATION > LIS CONFIGURATION, DISABLE THE LIS PROTOCOL AND ACTIVATE THE NEW CONFIGURATION, REBOOT THE PC AND WAIT FOR INITIALIZATION, RE-ENABLE THE LIS CONFIGURATION AND ACTIVATE THE CONFIGURATION. FOR A LONG-TERM SOLUTION, TWO SOFTWARE ANOMALIES HAVE BEEN IDENTIFIED AND WILL BE CORRECTED IN THE UPCOMING DXI 9000 V1.22 SOFTWARE RELEASE. THE IMPACTED USER IN IRELAND HAS NOT SUBMITTED ANY ADDITIONAL COMPLAINTS RELATED TO THIS ISSUE. BECKMAN COULTER IS CURRENTLY FOLLOWING ESTABLISHED PROCEDURES TO DETERMINE THE ROOT CAUSE. AN INVESTIGATION REPORT IS IN PROGRESS WITH A TARGET COMPLETION DATE OF 11 MARCH 2025. UPON COMPLETION OF THE INVESTIGATION REPORT, ADDITIONAL INVESTIGATION ACTIVITIES WILL BE CONDUCTED TO SUPPORT A CAPA TO IDENTIFY CORRECTIVE ACTIONS TO ADDRESS THE ROOT CAUSE.

    Additional Manufacturer Narrative · 0

    AN INTERNAL INVESTIGATION WAS PERFORMED AND SOFTWARE DESIGN ERRORS WERE IDENTIFIED. A FIELD ACTION (FA-25027) WILL ADDRESS THE ISSUE. H6: DUE TO SMARTSOLVE LIMITATIONS, THE EVALUATION CODE FOR INVESTIGATION CONCLUSION IS "4316: APPROPRIATE TERM/CODE NOT AVAILABLE". THE MOST ACCURATE CODING WOULD HAVE BEEN "58" FOR "CAUSE TRACED TO SOFTWARE CODING". NOTES: THE FOLLOWING SECTIONS WERE UPDATED FROM THE INITIAL MEDWATCH REPORT: H1/H2: DEVICE EVALUATION. H6: COMPONENT CODE, INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    ON 06FEB2025 THE CUSTOMER REPORTED THAT PATIENT SAMPLES WERE QUEUING ON THE AUTOMATION LINE TRACK BEHIND DXA 5000 INSTRUMENT SERIAL NUMBER (S/N) (B)(6) CONNECTED TO DXI 9000 INSTRUMENT S/N (B)(6). FIELD SERVICE ENGINEER (FSE) NOTICED THAT NO HARDWARE ERROR MESSAGES WERE GENERATED ON THE DXI 9000 INSTRUMENT INDICATING THAT SAMPLES WERE NOT BEING ASPIRATED. THIS ISSUE CAUSED A DELAY IN REPORTING PATIENT RESULTS. THE CUSTOMER REPORTED A PATIENT DEATH WHILE WAITING FOR THE RESULTS BEING PROCESSED. UPON THE INITIAL REPORT OF THE EVENT, THE CUSTOMER DID NOT ALLEGE WHETHER THE DELAY IN OBTAINING THE RESULTS CONTRIBUTED TO THE PATIENT'S DEATH. THE HSTNI RESULT FOR THIS PATIENT SAMPLE WAS ELEVATED (236.26 NG/L) COMPARED WITH THE EXPECTED VALUES FOR OVERALL POPULATION (99TH PERCENTILE URL (95% CL): 17.5 PG/ML (12.6 - 20.7 PG/ML)). PER DISCUSSION BETWEEN FIELD APPLICATION SPECIALIST (FAS) AND THE CUSTOMER ON 11FEB2025, THE CUSTOMER STATED THE PHYSICIANS WERE NOT WAITING ONLY FOR THE HSTNI RESULT TO DETERMINE A DIAGNOSIS. THE CUSTOMER DID NOT CONFIRM WHETHER THE DELAY IN OBTAINING THE RESULT LED TO A DELAY IN DIAGNOSIS OR TREATMENT; THE CUSTOMER ALSO DID NOT PROVIDE THE PATIENT¿S DIAGNOSIS AND DID NOT PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE PATIENT¿S PRESENTATION OR HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428354 DXI 9000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC 15099590732103

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death