BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2226048 · Received August 29, 2011

    Report

    Report Number
    2050012-2011-04808
    Event Type
    Malfunction
    Date Received
    August 29, 2011
    Date of Event
    July 30, 2011
    Report Date
    July 30, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BEC CUSTOMER TECHNICAL SUPPORT (CTS) RECOMMENDED THE USE OF PERSONAL PROTECTIVE EQUIPMENT BEFORE TROUBLESHOOTING. THE CUSTOMER HAD TRIED REPLACING THE CARTRIDGE CHEMISTRY (CC) SAMPLE SYRINGE BUT IT DID NOT RESOLVE THE ISSUE. THE CTS RECOMMENDED THAT THE CUSTOMER DISCONTINUE RUNNING THE CC SIDE OF THE INSTRUMENT UNTIL THE INSTRUMENT COULD BE EVALUATED BY A FIELD SERVICE ENGINEER (FSE). ON (B)(4) 2011, BEC FSE PERFORMED SERVICE ON THE INSTRUMENT. THE FSE REPLACED THE CC SAMPLE SYRINGE T-VALVE. THE FSE PRIMED THE INSTRUMENT, AND PERFORMED CALIBRATION AND QC WITHOUT ANY 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. BEC INTERNAL IDENTIFIER FOR THIS COMPLAINT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THERE WAS A FLUID LEAK FROM SAMPLE SYRINGE T-VALVE ON UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM. NO PATIENT SAMPLE WAS AFFECTED. 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 600 PRO SYNCHRON® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1