BEUDAMED
    FDA Adverse Event Summary report: N

    KINETIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE

    MDR report key: 2034508 · Received March 31, 2011

    Report

    Report Number
    2050012-2011-00819
    Date Received
    March 31, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 28, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JQB
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED. NO ADDITIONAL DETAILS WERE PROVIDED. INSTRUMENT/DEVICE NOT INVOLVED.

    Description of Event or Problem · 1

    BECKMAN COULTER INC. (BCI) IN (B)(4) REPORTED TWO BOXES OF GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT) THAT LEAKED. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE GAMMA-GLUTAMYL TRANSPEPTIDASE JQB BECKMAN COULTER INC. GGT REAGNET Z006038

    Patients

    Seq Age Sex Outcome Treatment
    1