BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXC 800 SYNCHRON CLINICAL SYSTEMS

    MDR report key: 864248 · Received May 2, 2007

    Report

    Report Number
    2050012-2007-00010
    Event Type
    Other
    Date Received
    May 2, 2007
    Date of Event
    April 2, 2007
    Report Date
    May 2, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER CUSTOMER, NO QC ISSUES WERE SEEN IN 2007. TWO DAYS LATER, THE CUSTOMER CONDUCTED DAILY MAINTENANCE AND QC, AND OBTAINED LOW FLYERS FOR ONE CONTROL. THE CUSTOMER THEN STARTED RUNNING PT SAMPLES FOR GLU ON A DIFFERENT INSTRUMENT IN THEIR LAB. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: THE FSE INSPECTED THE INSTRUMENT AND OBSERVED A MALFUNCTIONING STIRRER MOTOR. THE STIRRER MOTOR WAS REPLACED WHICH RESOLVED THE ISSUE. AFTER SERVICE COMPLETION, A PRECISION TESTING WAS PERFORMED WITH ACCEPTABLE RESULTS. A FAILED STIRRER MOTOR ASSEMBLY MAY HAVE CONTRIBUTED TO THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    PER BECKMAN COULTER INC. (BCI) CUSTOMER, INCORRECT GLUCOSE (GLUM) RESULTS WERE REPORTED FOR MULTIPLE PT SAMPLES THAT WERE GENERATED BY THE UNICEL DXC 800 SYNCHRON CLINICAL SYSTEMS. THE CUSTOMER INDICATED THAT ERRONEOUS GLUM RESULTS WERE REPORTED FOR APPROXIMATELY 100 PTS (SEE EXAMPLES IN B6). AFTER SERVICE COMPLETION, THE CUSTOMER RE-TESTED ALL PT SAMPLES FOR GLUM AND AMENDED ABOUT 100 RESULTS (SEE EXAMPLES IN B6). THERE IS NO INFORMATION REGARDING ANY EFFECTS TO PTS, BUT THE CUSTOMER HAS NOT BEEN INFORMED OF ANY INCIDENT RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 800 SYNCHRON CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. DXC 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other