BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2192376 · Received August 4, 2011

    Report

    Report Number
    2050012-2011-04238
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2011 BEC FIELD SERVICE ENGINEER (FSE) VISITED THE SITE. THE FSE REPLACED THE A/B SWITCH DRIVER. NO FURTHER LEAKING WAS FOUND ON THE INSTRUMENT THE FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES. BEC INTERNAL IDENTIFIER FOR THIS COMPLAINT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) AND REPORTED A LEAK FROM REAGENT PROBE ON UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM. MSDS WAS NOT REVIEWED, BUT THE FACILITY HAS EXPOSURE CONTROL PLAN. MEDICAL ATTENTION WAS NOT SOUGHT, 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