BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2211021 · Received August 13, 2011

    Report

    Report Number
    2050012-2011-04457
    Event Type
    Malfunction
    Date Received
    August 13, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 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
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2011. THE FSE REPLACED THE VACUUM LINE AND VALVE AND VERIFIED THE REPAIR PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT A LEAK FROM THEIR UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM. REAGENT PROBE A WAS LEAKING AND THE DRIP TRAY WAS FULL. THE CUSTOMER CHECKED THE PROBE FITTINGS AND SYRINGE BARREL, WHICH WERE ALL TIGHT. THE CUSTOMER REMOVED THE FITTING ON REAGENT PROBE A AND CLEANED INSIDE THE PROBE WITH A Q-TIP, RESEATED THE FITTING, AND PRIMED THE SYSTEM. THE PROBE CONTINUED TO LEAK. THE CUSTOMER REPLACED THE SYRINGE PLUNGER AND PRIMED THE SYSTEM. THE PROBE CONTINUED TO LEAK. THE CUSTOMER STATED THAT NO ERRONEOUS PATIENT RESULTS WERE GENERATED. 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