BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHRON LXI 725 CLINICAL SYSTEM

    MDR report key: 1200213 · Received October 6, 2008

    Report

    Report Number
    2050012-2008-00059
    Event Type
    Other
    Date Received
    October 6, 2008
    Date of Event
    September 9, 2008
    Report Date
    October 6, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SPECIFIC SAMPLE INFORMATION WAS SUPPLIED. QC WAS RUNNING LOW WHEN RUN THROUGH THE CLOSED TUBE ACCESSING (CTA) SYSTEM. THE INSTRUMENT WAS GIVING ULTRASONIC SURFACE DETECT ERRORS. THE CUSTOMER CLEANED THE PIPETTORS, BUT THE ERRORS CONTINUED. A SERVICE CALL WAS REQUESTED. FIELD SERVICE ENGINEER (FSE) WAS ON-SITE AND FOUND A SMALL INTERMITTENT LEAK ON THE SAMPLE SYRINGE (IN THE CTA). FSE ALSO NOTICED THAT THE FITTING ON TOP OF THE SAMPLE PROBE WAS LOOSE. FSE THEN RAN QC THROUGH THE CTA AND WAS ABLE TO SEE ADEQUATE SAMPLE BEING DISPENSED. AT THIS TIME, THERE WERE NO ULTRASONIC ERRORS ON THE ACCESS. ALTHOUGH HARDWARE ISSUES MAY HAVE CONTRIBUTED TO THIS EVENT, 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

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUS ACCUTNI RESULTS, GENERATED BY THE SYNCHRON LXI 725 CLINICAL SYSTEM. ONLY ONE EXAMPLE OF THE ERRONEOUS RESULTS WAS SUPPLIED. THE ORIGINAL ACCUTNI RESULT WAS "<0.01NG/ML" AND THE REPEAT RESULT WAS 0.05NG/ML. THE ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE LABORATORY IS NOT AWARE OF ANY CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LXI 725 CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA