BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® CK 2 X 400

    MDR report key: 2083663 · Received May 10, 2011

    Report

    Report Number
    2050012-2011-01597
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 13, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CKA
    PMA / PMN Number
    K883181
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPLACEMENT REAGENT WAS SENT TO THE CUSTOMER. NOTE: THE PRODUCT INFORMATION ON THE OTHER REAGENT INVOLVED IN THIS EVENT, SYNCHRON DBIL REAGENT, IS LISTED BELOW: PART NUMBER: 476856, LOT NUMBER: M01518, DATE OF MANUFACTURE: 11/17/2010, EXPIRATION DATE: 11/30/2012, PRODUCT CODE: JFM, 510(K): K934068.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO FLUID LEAKS FROM SYNCHRON CK AND SYNCHRON DBIL REAGENT CARTRIDGES ON UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM. NO INJURY WAS REPORTED AND THERE WAS NO EXPOSURE TO UNCOVERED WOUNDS OR MUCOUS MEMBRANES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® CK 2 X 400 CREATINE KINASE REAGENT CKA BECKMAN COULTER, INC. NA M101637

    Patients

    Seq Age Sex Outcome Treatment
    1