BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2222348 · Received August 25, 2011

    Report

    Report Number
    2050012-2011-04724
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INITIALLY REPORTED CALIBRATION FAILURE ON MC (MODULAR CHEMISTRY) ALBUMIN. IT WAS AFTER THE CUSTOMER PERFORMED MAINTENANCE ON THE INSTRUMENT. THE CUSTOMER RAISED THE MODULE TO TROUBLESHOOT AND FOUND IT WAS LEAKING UNDERNEATH. ON (B)(4) 2011, BEC FIELD SERVICE ENGINEER (FSE) PERFORMED SERVICE ON THE INSTRUMENT. THE FSE ISOLATED PROBLEM TO THE MC SIDE, AND FOUND A BAD T-VALVE ON MC SYRINGE. THE FSE REPLACED THE T-VALVE. CALIBRATION WAS PERFORMED WITH NO PROBLEMS NOTED. THE FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES. AS OF (B)(4) 2011, THE CUSTOMER HAS NOT CONTACTED BEC WITH REQUESTS FOR FURTHER ASSISTANCE FOR THIS ISSUE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THERE WAS A FLUID LEAK ON UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. MSDS WAS NOT REVIEWED, BUT THE FACILITY HAS AN EXPOSURE CONTROL PLAN. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION AND THERE WAS NO EFFECT TO PATIENT OR USER.

    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