BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DXA MAIN PRIMARY DRIVE DUAL ASSY

    MDR report key: 23273755 · Received October 12, 2025

    Report

    Report Number
    3006655511-2025-00006
    Event Type
    Malfunction
    Date Received
    October 12, 2025
    Date of Event
    September 18, 2025
    Report Date
    December 17, 2025
    Manufacturer
    BECKMAN COULTER BIOMEDICAL GMBH
    Product Code
    JJE
    UDI-DI
    15099590719654
    PMA / PMN Number
    K190298
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D: PRODUCT CODE CORRECTED BECKMAN COULTER IDENTIFIER IS CASE-(B)(4).

    Additional Manufacturer Narrative · 0

    BECKMAN CUSTOMER TECHNICAL SPECIALIST ASSISTED THE CUSTOMER TROUBLESHOOT OVER THE PHONE. THE CTS REVIEWED DXA EVENT LOGS THEY REVIEWED ERROR LOGS AND DXA SETTINGS, FINDING NO CONSISTENT ERRORS DURING TESTING CTS GUIDED THE CUSTOMER THROUGH REMOVING AND RELOADING THE PTH SAMPLE, AND IT WAS TESTED ON ANOTHER DXI ANALYZER SUCCESSFULLY. THE DXA WAS ALSO REBOOTED. CTS ATTEMPTED TO REPLICATE THE ERROR WITH A NEW TEST SAMPLE, AND THE TEST SAMPLE DID NOT SHOW ANY ERRORS AND WORKED AS EXPECTED. THE CTS WAS UNABLE TO REPRODUCE THE ISSUE. THE SAMPLE SUCCESSFULLY PROCESSED WITH NORMAL RESULTS AFTER BEING RELOADED. BASED ON THE CURRENT INFORMATION, THERE'S INSUFFICIENT EVIDENCE OF A SYSTEM MALFUNCTION, AND THE PROBABLE CAUSE IS UNKNOWN. 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 REPORTED A PARATHYROID INTRAOPERATIVE SPECIMEN (PTH) FAILED TO RUN ON THE DXI ANALYZER AFTER THE DXA MAIN PRIMARY DRIVE DUAL TRANSPORT AUTOMATION SYSTEM LOADED THE PATIENT SAMPLE. THE SAMPLE TRACKING LOG SHOWED THE SAMPLE WAS LOADED BUT DID NOT PROCESS. AN ERROR STATING "LAS TUBE EXITED THE CONNECTOR UNIT WITH NO TEST ORDERED" WAS DISPLAYED. THIS DELAY IN RESULTS IMPACTED PATIENT CARE, WHICH RESULTED IN THE PROLONGED SURGERY. THE PATIENT SAMPLE WAS REMOVED, RELOADED AND PROCESSED WITHOUT ERRORS ON ANOTHER DXI ANALYZER. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED TO THIS EVENT. THERE WAS NO HARM TO THE PATIENT DUE TO THE PROLONGED SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2746140 DXA MAIN PRIMARY DRIVE DUAL ASSY ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER BIOMEDICAL GMBH ASSY MAIN PRIMARY DRIVE DUAL - TRAN 15099590719654

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other