BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX9 ALX

    MDR report key: 1869848 · Received October 14, 2010

    Report

    Report Number
    2050012-2010-01019
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Date of Event
    September 28, 2010
    Report Date
    October 14, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K950958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED THE ODC.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING OBSTRUCTION DETECTION SAMPLE ASSEMBLY (ODC) THAT WAS LEAKING ON THE ION SELECTIVE ELECTRODE (ISE) PROBE ON THE SYNCHRON CX9 ALX ANALYZER. NO ERRONEOUS RESULTS HAVE BEEN GENERATED. NO INJURY WAS REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX9 ALX CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. CX9 ALX

    Patients

    Seq Age Sex Outcome Treatment
    1