BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN ENZYMATIC CARBON-DIOXIDE (CO2) REAGENT

    MDR report key: 2030106 · Received March 27, 2011

    Report

    Report Number
    2050012-2011-00818
    Event Type
    Malfunction
    Date Received
    March 27, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 24, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    KHS
    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 PROVIDED. THIS IS A REAGENT ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO CO2 ACID REAGENT LEAK. NO OPERATOR EXPOSURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN ENZYMATIC CARBON-DIOXIDE (CO2) REAGENT CO2 REAGENT KIT KHS BECKMAN COULTER INC. CO2 Z012004

    Patients

    Seq Age Sex Outcome Treatment
    1