BEUDAMED
    FDA Adverse Event Summary report: N

    UNICEL DXI WASH BUFFER II

    MDR report key: 2061768 · Received April 19, 2011

    Report

    Report Number
    2122870-2011-01046
    Date Received
    April 19, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 19, 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 ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER INC. (BCI) THAT THEY RECEIVED A NEW BOTTLE WASH BUFFER WHICH LEAKED. NO INJURY HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI WASH BUFFER II WASH BUFFER II, LDT BECKMAN COULTER INC. N/A 331700F

    Patients

    Seq Age Sex Outcome Treatment
    1