BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX/LX CREATININE KINASE (CK) KIT

    MDR report key: 1951817 · Received January 7, 2011

    Report

    Report Number
    2050012-2011-00075
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 8, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CKA
    PMA / PMN Number
    K883181
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT REAGENT WAS SENT TO THE CUSTOMER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE CREATININE KINASE (CK) REAGENT CARTRIDGE WAS LEAKING. NO INJURY WAS REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX/LX CREATININE KINASE (CK) KIT CREATININE KINASE (CK) KIT CKA BECKMAN COULTER INC. N/A M007612

    Patients

    Seq Age Sex Outcome Treatment
    1