BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMMA-GLUTAMYL TRANSFERASE REAGENT

    MDR report key: 2381371 · Received December 19, 2011

    Report

    Report Number
    2050012-2011-08476
    Event Type
    Malfunction
    Date Received
    December 19, 2011
    Date of Event
    November 28, 2011
    Report Date
    November 28, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JPZ
    PMA / PMN Number
    K971333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, CUSTOMER REPORTED THAT THEY RECEIVED GAMMA-GLUTAMYL TRANSFERASE (GGT) REAGENT THAT LEAKED DUE TO LOOSE CAPS. NO INJURIES OR EXPOSURE WERE REPORTED. BECKMAN COULTER SENT A REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMMA-GLUTAMYL TRANSFERASE REAGENT COLORIMETRIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE JPZ BECKMAN COULTER, INC. M108296

    Patients

    Seq Age Sex Outcome Treatment
    1