BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CX/LX ASO KIT

    MDR report key: 2032871 · Received March 29, 2011

    Report

    Report Number
    2050012-2011-00874
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 28, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPLACEMENTS WERE SENT TO THE CUSTOMER. CX/LX GGT KIT INFORMATION: PART NUMBER: 476846; LOT NUMBER: Z006038; DATE OF MANUFACTURE: 06/30/2010; FDA CODE: JQB; PRODUCT CODE NAME: KINETIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE; DEVICE CLASS: CLASS I; CLASSIFICATION PANEL: CLINICAL CHEMISTRY; C.F.R. SECTION: 862.1360 - GAMMA-GLUTAMYL TRANSPEPTIDASE AND ISOENZYMES TEST SYSTEM.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) STATING THAT THEY RECEIVED CX/LX ASO KIT AND CX/LX GGT KIT LEAKING. NO INJURY WAS REPORTED ON THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CX/LX ASO KIT ASO KIT JGS BECKMAN COULTER INC. NA M010683

    Patients

    Seq Age Sex Outcome Treatment
    1