BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2165877 · Received July 17, 2011

    Report

    Report Number
    2050012-2011-03220
    Event Type
    Malfunction
    Date Received
    July 17, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 15, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER TECHNICAL SUPPORT (CTS) DIRECTED THE CUSTOMER TO CHECK THE FITTING ON TOP OF THE CC SAMPLE PROBE AND SYRINGE ASSEMBLY. PER THE CUSTOMER ALL WERE PLACED AND OPERATING PROPERLY. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND DISCOVERED THAT THE WASH COLLAR WAS LEAKING. THE FSE REMOVED THE WASH VALVE AND FOUND WHITE PLASTIC SHAVINGS IN THE VALVE HEAD. THE FSE REMOVED THE FOREIGN MATERIAL, REASSEMBLED, AND PRIMED THE UNIT. REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT THE CHEMISTRY CARTRIDGE (CC) SAMPLE PROBE WAS LEAKING IN THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. NO INJURY OR OPERATOR EXPOSURE WAS REPORTED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1