BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARCHITECT C8000

    MDR report key: 765526 · Received August 3, 2006

    Report

    Report Number
    1628664-2006-00069
    Event Type
    Other
    Date Received
    August 3, 2006
    Date of Event
    July 12, 2006
    Report Date
    July 13, 2006
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS INSTRUCTED TO REPLACE THE 1 ML SYRINGES AND VALVES ON THE ARCHITECT C8000. POTASSIUM VALUES WERE ACCEPTABLE AFTER REPLACING ALL 1 ML SYRINGES. THE CUSTOMER REPLACED THE ICT MODULE AS A PRECAUTION. THE ARCHITECT SYSTEM OPERATIONS MANUAL INCLUDES ADEQUATE INFORMATION TO ADDRESS THE CUSTOMER'S OBSERVED PROBLEM SECTION 10, TROUBLESHOOTING AND DIAGNOSTICS, INCLUDES PROBABLE CAUSES WITH CORRECTIVE ACTIONS FOR "DEPRESSED CONCENTRATION ICT RESULTS, ENTIRE RUN, SINGLE ASSAY DEPRESSED CONCENTRATION K+ RESULTS, AND POOR PRECISION PHOTOMETRIC RESULTS (CSYSTEM)" CAUSES INCLUDE, BUT ARE NOT LIMITED TO SAMPLE CONTAINS FIBRIN OR CLOTS, 1 ML SYRINGES IN THE ICT ASPIRATION PUMP OR THE ICT REFERENCE SOLUTION PUMP ARE NOT SEATED CORRECTLY, ICT MODULE IS NOT PERFORMING AS EXPECTED, ICT CHECK VALVE ARE NOT CONNECTED CORRECTLY, ICT PROBE IS DAMAGED, ICT MODULE IS EXPIRED OR HAS EXCEEDED TIME OR SAMPLE WARRANTY. THE TROUBLESHOOTING STEPS TAKEN BY THE CUSTOMER ARE CONSISTENT WITH INFORMATION PROVIDED IN THE ARCHITECT SYSTEM OPERATIONS MANUAL, SECTION 10, TROUBLESHOOTING AND DIAGNOSTICS. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED LOWER THAN EXPECTED ARCHITECT C8000 POTASSIUM RESULTS. ONE EXAMPLE WAS PROVIDED. AN ARCHITECT C8000 POTASSIUM RESULT OF 2.4 MEQ/L WAS GENERATED ON A PATIENT SAMPLE THAT TESTED A 3.6 MEQ/L AT ANOTHER FACILITY NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT C8000 AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN