BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2182579 · Received July 28, 2011

    Report

    Report Number
    2050012-2011-03837
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 29, 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
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BEC CUSTOMER TECHNICAL SUPPORT (CTS) ADVISED THE CUSTOMER TO CLEAN THE EIC ACCORDING TO THE PROCEDURE OUTLINED IN THE INSTRUCTIONS FOR USE. CTS PROVIDED ALL CAUTIONS AND TIPS IN REMOVING DEBRIS CLOGGING THE EIC VALVE PORTS. THE CUSTOMER SUCCESSFULLY CLEANED THE EIC. CALIBRATION FOR ALL ELECTROLYTES PASSED AND QC WAS WITHIN ACCEPTABLE LIMITS. BEC IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE ELECTROLYTE INJECTION CUP (EIC) FROM THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM WAS OVERFLOWING. THE LEAK WAS CONTAINED WITHIN THE EIC. THE CUSTOMER FOUND SOME BLACK CRUSTY MATERIAL THAT WAS BLOCKING THE RIGHT VALVE. NO EFFECT TO PATIENT OR USER WAS REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 SYNCHRON® CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1