BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS WASH BUFFER II

    MDR report key: 2070709 · Received April 27, 2011

    Report

    Report Number
    2122870-2011-01042
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ROOT CAUSE WAS DETERMINED WITH THE INFORMATION SUPPLIED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) TO REPORT LEAKING WASH BUFFER II WHILE LOADING IT ON THE INSTRUMENT. THERE WAS NO REPORT OF INJURY IN CONNECTION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS WASH BUFFER II WASH BUFFER II JJE BECKMAN COULTER INC. NA NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1