BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® WASH BUFFER II

    MDR report key: 2120800 · Received June 10, 2011

    Report

    Report Number
    2122870-2011-01762
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    LDT
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION WAS PROVIDED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. REPORTED RECEIVING ONE LEAKING ACCESS WASH BUFFER II BOTTLE IN A BOX CONTAINING FOUR 1950ML BOTTLES. THERE WAS NO REPORT OF INJURY TO PATIENTS OR END USERS IN ASSOCIATION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® WASH BUFFER II GENERAL PURPOSE REAGENT LDT BECKMAN COULTER INC. NA 331773F

    Patients

    Seq Age Sex Outcome Treatment
    1