BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® SYSTEM

    MDR report key: 2148221 · Received July 2, 2011

    Report

    Report Number
    2050012-2011-02539
    Event Type
    Malfunction
    Date Received
    July 2, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE VISITED ON (B)(6) 2011. THE FIELD SERVICE ENGINEER (FSE) SUSPECTED THE CTS LEAK WAS CAUSED BY A FULL WASTE CANISTER CAUSING THE SYSTEM TO GET BACKED UP. AFTER THE WASTE CANISTER WAS EMPTIED AND THE FLOAT SWITCH WAS CLEANED, THE INSTRUMENT RETURNED TO NORMAL OPERATION. NO FURTHER CTS LEAKING COMPLAINT FILED AS OF (B)(6) 2011.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) A FLUID LEAK FROM CLOSED TUBE SAMPLING (CTS) ON UNICEL DXC 600 PRO SYNCHRON SYSTEM. BEC CUSTOMER TECHNICAL SUPPORT SUGGESTED DISABLING THE CTS AND DE-CAPPING THE SAMPLE TUBES UNTIL SERVICE ARRIVES. NO ONE WAS EXPOSED OR INJURED BY THE LEAK. THE CUSTOMER WAS WEARING GLOVES AND A LAB COAT. THERE IS A HAZARD MANAGEMENT PLAN IN PLACE. THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1