BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2182648 · Received July 28, 2011

    Report

    Report Number
    2050012-2011-03833
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 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
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2011 FOR THIS EVENT. THE FSE FOUND A CLOT IN THE MC SAMPLE PROBE WASH COLLAR VALVE. THE FSE REPLACED THE WASH COLLAR VALVE. BEC IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE MODULAR CHEMISTRY (MC) SAMPLE PROBE ON THEIR UNICEL DXC 800 SYNCHRON SYSTEM WAS DRIPPING WHEN THE INSTRUMENT WAS HOMED OR THE MC SAMPLE DELIVERY WAS PRIMED. 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 800 SYNCHRON® SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1