BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2163019 · Received July 15, 2011

    Report

    Report Number
    2050012-2011-03097
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 12, 2011
    Report Date
    June 12, 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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 AND INSPECTED THE SOURCE OF THE LEAK AND FOUND THE ELECTROLYTE INJECTION CUP (EIC) OVERFLOWING. THE FSE CLEANED THE EIC PORTS AND VALVE SEATS. THE REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THERE WAS A LEAK COMING FROM THE MODULAR CHEMISTRY (MC) SIDE OF THE UNICEL DXC 600 SYNCHRON CHEMISTRY ANALYZER. CUSTOMER STATED THAT NO ERRORS WERE GENERATED AND ALL CHEMISTRIES WERE OPERATING PROPERLY. THE CUSTOMER ALSO INDICATED THAT THE LIQUID WAS CLEAR AND THAT THE SOURCE OF THE LEAK WAS UNKNOWN. NO INJURY OR OPERATOR EXPOSURE WAS REPORTED FOR THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1