BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800

    MDR report key: 2254200 · Received September 19, 2011

    Report

    Report Number
    2050012-2011-05563
    Event Type
    Malfunction
    Date Received
    September 19, 2011
    Date of Event
    August 22, 2011
    Report Date
    August 22, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT AFTER SHE RECEIVED AN UNRECOVERED MC (MODULAR CHEMISTRY) SAMPLE PROBE OBSTRUCTION TO REPLACE THE SAMPLE PROBE ON THE UNICEL DXC 800, SHE FOUND WHAT APPEARED TO BE A DEIONIZED WATER LEAK AT THE TOP OF THE SAMPLE CRANE NEAR THE OBSTRUCTION DETECTION TRANSDUCER. ON THE SAME DAY, THE FIELD SERVICE ENGINEER (FSE) VERIFIED THAT THE WATER WAS LEAKING FROM THE MC CLOT SENSOR. THE FSE RETURNED THE NEXT DAY, (B)(6) 2011, TO REPLACE THE CLOT SENSOR. THE CUSTOMER STATED THAT THE ISSUE OCCURRED WHILE RUNNING THE TWICE WEEKLY ISE (ION-SELECTIVE ELECTRODE) (B)(4) BLEACH CLEANING; THEREFORE, NO PATIENTS WERE HARMED SINCE NO PATIENT SAMPLES WERE RUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 800 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXC 800

    Patients

    Seq Age Sex Outcome Treatment
    1