BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX9 ALX

    MDR report key: 2123908 · Received June 14, 2011

    Report

    Report Number
    2050012-2011-02285
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 18, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJC
    PMA / PMN Number
    K950958
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NEW SAMPLE PROBE WAS SENT TO CUSTOMER AND CUSTOMER IS TO REPLACE IT. NO FURTHER SAMPLE PROBE LEAKING COMPLAINT FILED AS OF 05/31/11. HARDWARE IS THE ROOT CAUSE FOR THIS EVENT. AN MDR NUMBER 2050012-2011-02284 IS ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) AND REPORTED THAT SAMPLE PROBE, THAT WAS INSTALLED THE DAY BEFORE ON SYNCHRON CX9 ALX, IS BENT AND LEAKING. 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 JJC BECKMAN COULTER INC. CX9 ALX NA

    Patients

    Seq Age Sex Outcome Treatment
    1