BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2682118 · Received August 5, 2012

    Report

    Report Number
    2050012-2012-01415
    Event Type
    Malfunction
    Date Received
    August 5, 2012
    Date of Event
    July 11, 2012
    Report Date
    July 11, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 ALL THE CHEMISTRIES ON THE MODULAR CHEMISTRIES (MC) SIDE OF THE UNICEL DXC 800 SYNCHRON SYSTEM FAILED CALIBRATION AFTER PERFORMING WEEKLY MAINTENANCE. CUSTOMER REPORTED THAT THEY NOTICED THE MC SAMPLE COLLAR WASHER WAS NOT ASPIRATING THE FLUID AWAY, AND DURING CALIBRATION, LEAKING FLUID FROM THE COLLAR WASHER AND DRIBBLED ACROSS THE MC CUP AREA. CUSTOMER REPORTED THAT THE FLUID LEAK WAS CONTAINED INSIDE THE INSTRUMENT. 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) OBSERVED A CLOT / OCCLUSION IN THE MODULAR CHEMISTRY PROBE VACUUM VALVE. THE FSE REMOVED, CLEANED AND REINSTALLED THE VALVE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1