BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2292311 · Received October 13, 2011

    Report

    Report Number
    2050012-2011-06233
    Event Type
    Malfunction
    Date Received
    October 13, 2011
    Date of Event
    September 13, 2011
    Report Date
    September 13, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THERE WAS A LEAK FROM HYDROPNEUMATIC AREA OF THE UNICEL DXC 800 SYNCHRON SYSTEM. CUSTOMER REPORTED THAT SHE WAS RUNNING QUALITY CONTROL AND THE SYSTEM WENT TO STOP MODE. CUSTOMER REPORTED THAT THERE WAS A LEAK ON THE FLOOR. CUSTOMER REPORTED THAT NO ERRONEOUS RESULTS WERE GENERATED. THERE WAS NO REPORT OF ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT BEC FIELD SERVICE ENGINEER (FSE) DETERMINED THAT THE WASH SOLUTION FLOAT SWITCH WAS RESPONSIBLE FOR THE LEAK AND THAT THE LEAKING FLUID WAS WASH SOLUTION. THE FSE REPLACED THE WASH SOLUTION CANISTER FLOAT SWITCH AND RESOLVED THE ISSUE.

    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. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1