BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2240024 · Received September 8, 2011

    Report

    Report Number
    2050012-2011-05081
    Event Type
    Malfunction
    Date Received
    September 8, 2011
    Date of Event
    August 8, 2011
    Report Date
    August 9, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT A LEAK WAS OBSERVED IN THE AREA OF THE MODULAR CHEMISTRY REAGENTS, BUT COULD NOT TELL THE SOURCE. FIELD SERVICE ENGINEER (FSE) VISITED ON (B)(4) 2011, BUT COULD NEITHER LOCATE THE SOURCE NOR REPRODUCE THE LEAK. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT A FLUID LEAK WAS OBSERVED FROM UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM. THE CUSTOMER WAS WEARING GLOVES AND A LAB COAT AT THE TIME OF THE EVENT. NO ONE WAS INJURED OR EXPOSED TO BIOHAZARDOUS OR CHEMICAL MATERIAL. 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 SYNCHRON® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXC 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1