BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 1853399 · Received October 5, 2010

    Report

    Report Number
    2050012-2010-00871
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 6, 2010
    Report Date
    October 4, 2010
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) REPLACED THE T-VALVE. UPON RECUR, CHEMISTRY RESULTS COULD BE IMPACTED AND INCORRECT CHEMISTRY RESULTS COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A CARTRIDGE CHEMISTRY SAMPLE PROBE THAT WAS LEAKING ON UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. NO INJURY WAS REPORTED, AND THERE WAS NO EFFECT TO PATIENTS OR TO THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMSTRY ANALYZER JJE BECKMAN COULTER, INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1