BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI WASH BUFFER

    MDR report key: 2200509 · Received August 11, 2011

    Report

    Report Number
    2122870-2011-02574
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    LDT
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ROOT CAUSE WAS DETERMINED FOR THE LEAKING WITH THE INFORMATION SUPPLIED. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    A BECKMAN COULTER, INC. (BEC) (B)(4) PERSONNEL REPORTED RECEIVING ONE (1) DXI WASH BUFFER CUBETAINER THAT WAS LEAKING. THREE (3) WASH BUFFER BOXES WERE AFFECTED BY THE ONE (1) LEAKING WASH BUFFER CUBETAINER. NO EFFECT TO PATIENTS OR END USERS WAS REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI WASH BUFFER GENERAL PURPOSE REAGENT LDT BECKMAN COULTER INC. N/A 331814F

    Patients

    Seq Age Sex Outcome Treatment
    1