BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2052366 · Received April 12, 2011

    Report

    Report Number
    2050012-2011-01091
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE FOR THE BUBBLE GENERATOR AND AB VALVE WAS NOTED. THE CTS HAD CUSTOMER CLOSE FILES AND COLD BOOT AFTER RE-INSTALLING THE SAMPLE CAROUSEL. THE CTS CALLED THE CUSTOMER AND VERIFIED THAT THE THERE WAS NO MORE LEAKING ON THE INSTRUMENT. THE CUSTOMER WAS TO CALL BACK IF PROBLEM COMES BACK, BUT THERE HAS BEEN NO FURTHER LEAKING COMPLAINT FILED AS OF (B)(6) 2011.

    Description of Event or Problem · 1

    WHILE TROUBLESHOOTING FOR AUTOLOADER POSITION ERROR WITH BCI CUSTOMER TECHNICAL SPECIALIST (CTS)'S ASSISTANCE, A CUSTOMER FOUND FLUID LEAKAGE UNDER THE REAGENT PROBES ON THE BLACK DRIP TRAY OF UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1