BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX9 ALX

    MDR report key: 1577957 · Received January 14, 2010

    Report

    Report Number
    2050012-2010-00006
    Event Type
    Malfunction
    Date Received
    January 14, 2010
    Date of Event
    January 5, 2010
    Report Date
    January 14, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CGX
    PMA / PMN Number
    K950958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS REQUESTED ON 12/30/2009 FOR A REAGENT PROBE LEAKING COMPLAINT: A FIELD SERVICE ENGINEER (FSE) CLEANED THE CREATININE CUP AND REPLACED THE CREATININE LAMP. CUSTOMER RETESTED 20 PREVIOUSLY TESTED PATIENT SAMPLES AND ALL REPEATED RESULTS MATCHED THE ORIGINAL RESULTS. A FOLLOW-UP SERVICE WAS GENERATED BY A HOTLINE TO CONFIRM THE SYSTEM ACCURACY, AND THE ENTIRE CREATININE MODULE WAS REPLACED AS A PRECAUTION. THE INSTRUMENT IS PERFORMING WITH QC SPECIFICATIONS WITH RESPECT TO CONTROLS AND REPRODUCIBILITY. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING A FALSE HIGH CREATININE (CRE3) RESULT GENERATED BY THE SYNCHRON CX9 ALX ANALYZER. THE INITIAL RESULT OF 2.2 MG/DL WAS REPORTED OUT OF THE LAB AND QUESTIONED BY THE PHYSICIAN. THE PATIENT WAS SENT TO A DIFFERENT LAB AND RECEIVED A CREATININE RESULT OF 0.71 MG/DL. AFTER FSE SERVICED THE INSTRUMENT, THE CUSTOMER RERAN THE ORIGINAL SAMPLE AND IT GENERATED A LOWER RESULT OF 0.75 MG/DL. THE CRE3 RESULT WAS AMENDED. IT IS UNKNOWN IF TREATMENT WAS INITIATED OR WITHHELD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1