BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXC 700 AU CLINICAL CHEMISTRY ANALYZER

    MDR report key: 23550554 · Received November 13, 2025

    Report

    Report Number
    9612296-2025-00989
    Event Type
    Injury
    Date Received
    November 13, 2025
    Date of Event
    October 15, 2025
    Report Date
    November 13, 2025
    Manufacturer
    BECKMAN COULTER, INC
    Product Code
    JJE
    UDI-DI
    14987666542545
    PMA / PMN Number
    K161837
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER PERFORMED TROUBLESHOOTING WITH THE ASSISTANCE OF A BECKMAN CUSTOMER TECHNICAL SPECIALIST (CTS). CTS RECOMMENDED THAT THEY ESTABLISH A PLAN TO VISUALLY VERIFY ABNORMAL (ABN) FLAGS, CONSULT WITH THEIR LABORATORY PATHOLOGIST, OR USE AN ALTERNATIVE TESTING METHOD. THE CUSTOMER WAS SATISFIED AND RESUMED NORMAL OPERATIONS. BASED ON THE INFORMATION AVAILABLE, THERE WAS NO INDICATION OF AN ANALYZER OR REAGENT MALFUNCTION, AND NO HARDWARE PARTS WERE REPLACED. THE CAUSE APPEARS TO BE SAMPLE-SPECIFIC. THE BECKMAN COULTER INTERNAL IDENTIFIER IS (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE DXC 700 AU CLINICAL CHEMISTRY ANALYZER GENERATED TOTAL BILIRUBIN PATIENT RESULTS FLAGGED AS ABNORMAL (ABN) DUE TO LIPEMIA, ICTERUS, HEMOLYSIS (LIH) LEVELS. THE CUSTOMER WAS UNABLE TO VISUALLY VERIFY THE LIH INTERFERENCE, WHICH CAUSED A DELAY IN REPORTING THESE RESULTS. THE CUSTOMER INDICATED AN IMPACT ON PATIENT CARE; HOWEVER, THEY DID NOT PROVIDE SPECIFIC DETAILS DESPITE MULTIPLE ATTEMPTS BY BECKMAN TO GATHER MORE INFORMATION. THERE WAS NO REPORT OF DEATH ASSOCIATED WITH THIS EVENT. PATIENT DATA OR DEMOGRAPHICS WERE NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1882676 DXC 700 AU CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC DXC 700 AU-10E CHEMISTRY ANALYZER DXC 700 AU WITH ISE N/A 14987666542545

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other