BEUDAMED
    FDA Adverse Event Summary report: N

    SYNCHRON CREATINE KINASE REAGENT

    MDR report key: 2132115 · Received June 17, 2011

    Report

    Report Number
    2050012-2011-02260
    Date Received
    June 17, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 17, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CGS
    PMA / PMN Number
    K883181
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BOTH REAGENT CARTRIDGES WERE LEAKING AND FROM THE PICTURES SENT IT APPEARS THE CAP WAS NOT ON CORRECTLY. DIGOXIN REAGENT: CATALOG NUMBER : 650182; LOT NUMBER: M102172; CLASSIFICATION CODE KXT; THE 510K: K982935. DATE OF MANUFACTURE: 03/25/2011.

    Description of Event or Problem · 1

    BECKMAN COULTER INC. (BCI) (B)(4) REPORTED CREATINE KINASE REAGENT AND DIGOXIN REAGENT LEAK. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CREATINE KINASE REAGENT CREATINE KINASE REAGENT CGS BECKMAN COULTER INC. CREATINE KINASE REAGENT M103415

    Patients

    Seq Age Sex Outcome Treatment
    1