BEUDAMED
    FDA Adverse Event Death Summary report: N

    DXC 700 AU CLINICAL CHEMISTRY ANALYZER

    MDR report key: 18432406 · Received January 2, 2024

    Report

    Report Number
    9612296-2024-00001
    Event Type
    Death
    Date Received
    January 2, 2024
    Date of Event
    December 14, 2023
    Report Date
    January 2, 2024
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    UDI-DI
    14987666542545
    PMA / PMN Number
    K161837
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON 13 DEC 2023, BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) PERFORMED MONTHLY MAINTENANCE AND PREVENTATIVE MAINTENANCE ON THE CUSTOMER'S DXC 700 AU #1, SN (B)(6). ON 14 DEC 2023, FSE RETURNED ONSITE TO PERFORM SCHEDULED MAINTENANCE ON THE CUSTOMER'S OTHER ANALYZER, DXC 700 AU #2, SN (B)(6). ON 14 DEC 2023, FSE PERFORMED CHECKS AND CALIBRATION ON DXC 700 AU #1 AND THE INSTRUMENT WAS RELEASED BACK TO THE CUSTOMER. FSE ASKED THE CUSTOMER IF SCHEDULED MAINTENANCE COULD BE PERFORMED ON DXC 700 AU #2, CUSTOMER ACKNOWLEDGED AND AGREED. QUALITY CONTROL (QC) WAS BEING RUN ON DXC 700 AU #1 AT THIS TIME. ON 14 DEC 2023, A STAT ER PATIENT SAMPLE CAME IN, AND THE CUSTOMER STATED THAT THEY WERE UNABLE TO RUN ¿CHEMISTRIES¿ DUE TO BOTH INSTRUMENTS BEING IN-USE/DOWN. THE ER PATIENT PENDING STAT CHEMISTRY RESULTS PASSED AWAY. ON 15 DEC 2023, CUSTOMER NOTIFIED BECKMAN COULTER FSE OF THE REPORT OF THE PATIENT DEATH. UPON FOLLOW UP CALL WITH BECKMAN COULTER SERVICE TEAM, THE LABORATORY SUPERVISOR INDICATED THE ANALYZERS WERE NOT AVAILABLE FOR 2 HOURS. BECKMAN COULTER QUALITY ASSURANCE ATTEMPTED MULTIPLE TIMES FROM 18 DEC 2023 TO 21 DEC 2023 TO CONTACT THE LABORATORY FOR MORE DETAILS INCLUDING THE PENDING CHEMISTRIES, THE PATIENT¿S DIAGNOSIS, THE CAUSE OF THE PATIENT¿S DEATH, AND THE INSTRUMENT STATUS WITH THE LABORATORY¿S PHONE LINE AND THE MANAGER¿S CELLPHONE UNSUCCESSFULLY. THERE WAS NO FOLLOW UP RECEIVED FROM THE CUSTOMER. THERE WAS NO ALLEGED DELAY OF RESULT LEADING TO DELAY OF TREATMENT AND/OR DIAGNOSIS FOR THIS PATIENT¿S DEATH. PER FSE AND CUSTOMER, THE CALIBRATIONS ON DXC 700 AU #1 WERE COMPLETED AND THE INSTRUMENT WAS RUNNING QC WHEN EVENT OCCURRED. THE FSE VERIFIED INSTRUMENT PERFORMANCE. THERE IS INSUFFICIENT INFORMATION REGARDING THE PATIENT AND THE EVENT TO DETERMINE IF THE DELAY IN RESULTS IS ATTRIBUTED TO THE PATIENT¿S DEATH. THERE IS NO EVIDENCE OF SYSTEM MALFUNCTION CAUSING THE EVENT. SECTION A2, A4 AND A5: INFORMATION NOT PROVIDED BY CUSTOMER. THE BECKMAN COULTER INTERNAL IDENTIFIER IS (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER INFORMED THE BECKMAN FIELD SERVICE ENGINEER (FSE) OF AN EMERGENCY ROOM (ER) PATIENT THAT HAD PASSED AWAY WHILE A STAT SAMPLE WAS UNABLE TO BE PROCESSED FROM THE DXC 700 AU ANALYZER, SERIAL NUMBER (SN) (B)(6). THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS OR DATA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655280 DXC 700 AU CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER DXC 700 AU-10E CHEMISTRY ANALYZER DXC 700 AU WITH ISE 14987666542545

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death