BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2252228 · Received September 16, 2011

    Report

    Report Number
    2050012-2011-05589
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 17, 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
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011, FOR THIS EVENT. THE FSE DISASSEMBLED AND CLEANED THE EIC AND VALVES. THE FSE ALSO CLEANED THE CREATININE MODULE AND THE LAMP WAS CALIBRATED (UNRELATED TO REPAIRS ADDRESSING THE LEAK). (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT THERE WAS A BLUE-GREEN LEAK UNDER THE ELECTROLYTE INJECTION CUP (EIC) IN THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE CUSTOMER INDICATED THAT THE LIQUID DID NOT APPEAR TO BE FRESH. THE CUSTOMER INSPECTED THE EIC AND DID NOT OBSERVE DISCONNECTED TUBING. NO INJURY OR OPERATOR EXPOSURE WAS REPORTED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER INC. DXC 800 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1