BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL ® DXC600I SYNCHRON ® ACCESS ® CLINICAL SYSTEM

    MDR report key: 2240424 · Received September 9, 2011

    Report

    Report Number
    2122870-2011-03396
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 9, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CTS INFORMED THE CUSTOMER THAT WHEN LOADING A NEW BOTTLE OF WASH BUFFER II ON THE INSTRUMENT, IT IS POSSIBLE TO CAUSE AN OVERFLOW DUE TO SQUEEZING THE BOTTLE. CTS INSTRUCTED THE CUSTOMER TO CHECK THE RESERVOIR FOR CRACKS AND WASH BUFFER II BOTTLE. THE CUSTOMER FOUND NO CRACKS IN THE RESERVOIR AND NO ISSUES WITH THE WASH BUFFER II BOTTLE. SERVICE WAS NOT DISPATCHED FOR THIS EVENT SINCE THE CUSTOMER IS NOT QUESTIONING HARDWARE. A CLEAR ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) TO REPORT A LEAK FROM THE OVERFLOW HOLE ON THE WASH BUFFER RESERVOIR ON THE UNICEL DXC600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER NOTED THE LEAK AFTER CHANGING THE BOTTLE. THE CUSTOMER CLEANED THE SPILL DURING TROUBLESHOOTING WITH BEC CUSTOMER TECHNICAL SUPPORT (CTS), THE CUSTOMER DISCOVERED THE LEAK OCCURRED WHILE LOADING A BOTTLE OF WASH BUFFER II ON THE INSTRUMENT. THE CUSTOMER DID NOT REPORT AN AFFECT TO PATIENTS OR END USERS IN ASSOCIATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL ® DXC600I SYNCHRON ® ACCESS ® CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE JJE BECKMAN COULTER INC. DXC 600I 800524

    Patients

    Seq Age Sex Outcome Treatment
    1