BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2242591 · Received September 10, 2011

    Report

    Report Number
    2050012-2011-05059
    Event Type
    Malfunction
    Date Received
    September 10, 2011
    Date of Event
    August 13, 2011
    Report Date
    August 13, 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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2011, FIELD SERVICE ENGINEER (FSE) CHECKED THE VACUUM AT WASH COLLAR, AND THERE WAS NO VACUUM. THE FSE REPLACED REAGENT PROBE A WASH COLLAR VALVE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT REAGENT PROBE B COLLAR WASH ON UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM WAS LEAKING FLUID. THE CUSTOMER FOUND FLUID ON FLOOR OF THE REAGENT CAROUSEL AND IN BLACK TRAY OVER REAGENT CAROUSEL. FLUID IS CONTAINED TO THE ANALYZER. 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