BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2821597 · Received November 6, 2012

    Report

    Report Number
    2050012-2012-01792
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 12, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THERE WAS A LEAK FROM THE CARTRIDGE CHEMISTRY SAMPLE PROBE ON THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. THE CUSTOMER STATED THAT THE FLUID LEAKED ONTO THE TOP END EVAPORATION COVERS, INTO THE INSTRUMENT, AND ONTO THE LABORATORY FLOOR. THE CUSTOMER WAS WEARING A LAB COAT, GLOVES, AND EYE PROTECTION AT THE TIME OF THE EVENT. MSDS WAS NOT REVIEWED, BUT THE FACILITY HAS AN EXPOSURE CONTROL PLAN. THERE WAS NO REPORT OF INJURY OR EXPOSURE, AND MEDICAL ATTENTION WAS NOT SOUGHT. NO ERRONEOUS PATIENT RESULTS WERE GENERATED. BEC FIELD SERVICE ENGINEER NOTED THE EIC (ELECTROLYTE INJECTION CUP) AND FLOWCELL WASTE TUBE WERE OVERFLOWING. THE FSE DID NOT FIND LEAKING FROM THE SAMPLE PROBE. THE FSE NOTED THE ISE WASTE TUBING WAS PINCHED BENEATH THE ISE MODULE AND BEHIND THE PUMP BOX, AND REROUTED THE LINE. THE REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES AND THE RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1