BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2182530 · Received July 28, 2011

    Report

    Report Number
    2050012-2011-03839
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 30, 2011
    Report Date
    June 30, 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
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BEC CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER WITH TIGHTENING THE BOLT. THE CUSTOMER STATED THAT THE LINE CONNECTING TO THE BLACK FITTING APPEARED LIKELY TO FALL OFF AGAIN. ON (B)(6) 2011, A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. THE FSE REPLACED THE NO FOAM ASSEMBLY AND NO ADDITIONAL LEAKS WERE OBSERVED. BEC IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THEIR UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM'S NO FOAM BOTTLE WAS LEAKING NO FOAM. THE CUSTOMER STATED THAT A BLACK FITTING ON THE SIDE OF THE LID WAS LEAKING. 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