BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHANOL KIT

    MDR report key: 1970645 · Received January 25, 2011

    Report

    Report Number
    2050012-2011-00223
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Date of Event
    December 29, 2010
    Report Date
    December 29, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    DKC
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ONE ETHANOL (ETOH) REAGENT KIT LEAK. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHANOL KIT ETHANOL KIT 2X150 TEST DKC BECKMAN COULTER INC. ETOH KIT M004395

    Patients

    Seq Age Sex Outcome Treatment
    1