BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2636516 · Received July 2, 2012

    Report

    Report Number
    2050012-2012-01540
    Event Type
    Malfunction
    Date Received
    July 2, 2012
    Date of Event
    June 5, 2012
    Report Date
    June 5, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT WHEN THEY WERE PERFORMING MAINTENANCE ON THE UNICEL DXC 600 SYNCHRON SYSTEM CUVETTE WASH TOWER, THEY NOTICED A SMALL AMOUNT OF FLUID, APPROXIMATELY 2 ML, UNDERNEATH REAGENT PROBE "A". CUSTOMER REPORTED THAT THE FLUID WAS COMPLETELY CONTAINED IN THE SPILL RESERVOIR ON THE REACTION WHEEL COVER. CUSTOMER REPORTED THAT THE LEAKED LIQUID SEEMED A LITTLE SOAPY. CUSTOMER REPORTED THAT ERRONEOUS RESULTS WERE NOT GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) REPLACED THE SAMPLE PROBES, A1 SMART MODULE, THE A/B VALVE ASSEMBLY, THE WASTE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600 SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1