BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2605423 · Received June 8, 2012

    Report

    Report Number
    2050012-2012-01224
    Event Type
    Malfunction
    Date Received
    June 8, 2012
    Date of Event
    May 14, 2012
    Report Date
    May 14, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 THE CARTRIDGE CHEMISTRY (CC) SIDE OF THE UNICEL DXC 800 SYNCHRON SYSTEM WAS GIVING LEVEL SENSE ERRORS WHEN THEY TRIED TO RUN QUALITY CONTROL (QC). CUSTOMER REPORTED THAT THERE WAS A WATER LEAK UNDER THE CC REAGENT SYRINGE. CUSTOMER REPORTED THAT THE LEAKED FLUID WAS CONFINED TO THE AREA UNDER THE REAGENT SYRINGE AND DID NOT LEAK ONTO THE FLOOR. CUSTOMER REPORTED THAT THE AMOUNT OF WATER THAT LEAKED WAS ABOUT 20 TO 30 ML, AND COVERED AN AREA OF ABOUT ONE FOOT BY 2.5 INCHES UNDER THE REAGENT SYRINGE. 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) DETERMINED THE LEAK WAS RELATED TO EITHER THE SHEAR T-VALVE OR THE SYRINGE. THE FSE REMOVED AND REPLACED THE SHEAR T-VALVE AND THE SYRINGE.

    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