BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2853547 · Received December 3, 2012

    Report

    Report Number
    2050012-2012-01894
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 6, 2012
    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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE CARTRIDGE CHEMISTRY REAGENT PROBE B ON THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM WAS LEAKING. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING A LAB COAT, GLOVES, AND GOGGLES AT THE TIME OF THE EVENT. MSDS WAS NOT REVIEWED, BUT THE FACILITY HAS AN EXPOSURE CONTROL PLAN. THERE WAS NO REPORT OF INJURY OR EXPOSURE, AND MEDICAL ATTENTION WAS NOT SOUGHT. NO ERRONEOUS PATIENT RESULTS WERE GENERATED. SERVICE WAS DISPATCHED ON (B)(4) 2012. BEC FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THE CARTRIDGE CHEMISTRY REAGENT PROBE B WAS LEAKING. THE FSE FOUND THAT THE DEBRIS WAS PREVENTING PROPER OPERATION OF THE VALVE THAT CONTROLS THE WASH TO THE COLLAR WASH. THE FSE CLEARED THE DEBRIS FROM THE VALVE. SERVICE ACTIVITY PERFORMED WAS VERIFIED PER ESTABLISHED PROCEDURES, AND THE RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS.

    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