BEUDAMED
    FDA Adverse Event Summary report: N

    UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN REAGENT

    MDR report key: 1912086 · Received December 1, 2010

    Report

    Report Number
    2050012-2010-01459
    Date Received
    December 1, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 4, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CDQ
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    A BECKMAN COULTER INC. (BCI) EMPLOYEE REPORTED A LOOSE BUN REAGENT CAPS THAT LEAKED. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN REAGENT BUN REAGENT CDQ BECKMAN COULTER INC. BUN REAGENT Z004019

    Patients

    Seq Age Sex Outcome Treatment
    1