BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2220633 · Received August 23, 2011

    Report

    Report Number
    2050012-2011-04736
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 10, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS ALSO GIVING "CC SAMPLE CUVETTE NO FLUID DETECTED" ERRORS. ON (B)(4) 2011, BEC FIELD SERVICE ENGINEER (FSE) PERFORMED SERVICE ON THE INSTRUMENT. THE CUSTOMER STATED TO THE FSE THAT THEY NOTICED WATER BY REAGENT SYRINGE AND REAGENT PROBE B. THE FSE REPLACED THE T-VALVE. THE FSE PRIMED THE INSTRUMENT AND OBSERVED NO LEAKING. AS OF (B)(4) 2011, THE CUSTOMER HAS NOT CONTACTED BECKMAN WITH REQUESTS FOR FURTHER ASSISTANCE FOR THIS ISSUE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) CONCERNING A FLUID LEAK FROM CARTRIDGE CHEMISTRY (CC) SAMPLE PROBE AND SAMPLE SYRINGE 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