BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARCHITECT C8000

    MDR report key: 798859 · Received December 18, 2006

    Report

    Report Number
    1628664-2006-00096
    Event Type
    Other
    Date Received
    December 18, 2006
    Date of Event
    November 21, 2006
    Report Date
    November 21, 2006
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE DETERMINED THE ICT ASPIRATION PUMP WAS CONTAMINATED AND NOT FUNCTIONG PROPERLY. FIELD SERVICE RESOLUTION INVOLVED CLEANING THE ICT ASPIRATION PUMP, FOLLOWED BY PERFORMANCE VERIFICATION OF A PASSING CALIBRATION AND CONTROL RUN. A REVIEW OF THE SERVICE HISTORY DETERMINED THE SYSTEM INTEGRATION BEGAN ON 09/18/06, THEREFORE THE ICT MODULE ASSOCIATED WITH THE COMPLAINT HAD EXCEEDED THE 2 MONTH ON BOARD WARRANTY CLAIM. THE SERVICE HISTORY BETWEEN 11/15/06 AND 12/13/06 IDENTIFIED FOUR DIFFERENT ISSUES RELATED TO OPERATOR ERROR THAT WERE RESOLVED BY TRAINING. ANOTHER COMPLAINT OPENED ON 12/07/06 INDICATED THE ACID WASH BULK SOLUTION INSTALLED ON 11/04/06 WAS NOT BEING USED, AND FIELD SERVICE DETERMINED THAT FITTINGS/CONNECTIONS WERE LOOSE. THE OPERATIONS MANUAL INCLUDES SUFFICIENT LABELING WITH REGARD TO THE ICT MODULE'S WARRANTY, MAINTENANCE, REPLACEMENT, AND TROUBLESHOOTING THE CUSTOMER'S ISSUE. THE WARRANTY IS STATED IN THE FORWARD SECTION. SECTION 9 SERVICE AND MAINTENANCE INSTRUCTS THE USER TO: DAILY- CHECK THE 1 MI SYRINGES FOR LEAKS DAILY; WEEKLY - CHECK THE ICT PROBE AND TUBING; MONTHLY - CHECK THE DISPENSE COMPONENTS, SYRINGES AND VALVES, AND THE ICT DRAIN TIP; AND QUARTERLY - CHANGE THE 1 ML SYRINGES, ICT ASP CHECK VALVE, AND ICT REF CHECK VALVE. SECTION 10 TROUBLESHOOTING AND DIAGNOSTICS INCLUDES PROBABLE CAUSES AND CORRECTIVE ACTIONS FOR THE OBSERVED PROBLEMS "CONTROLS OUT OF RANGE, AND "ERRATIC RESULTS, POOR PRECISION - ICT RESULTS." PROBABLE CAUSES INCLUDE, BUT ARE NOT LIMITED TO, "HARDWARE FAILURE - ICT ASPIRATION PUMP AND TUBING," RESOLVED BY CONTACTING CUSTOMER SUPPORT; AND"ICT MODULE IS EXPIRED OR HAS EXCEEDED TIME OR SAMPLE WARRANTY (> 2 MONTHS AFTER INSTALLATION OR > 15,000 SAMPLES)," RESOLVED BY CHANGING THE ICT MODULE. OTHER CAUSES AND CORRECTIVE ACTIONS ARE LISTED, AND SECTION 9 COMPONENT REPLACEMENT IS REFERENCED FOR INSTRUCTIONS TO REPLACE THE ICT MODULE, PROBE, AND ASSOCIATED SYRINGES AND TUBING. THE INVESTIGATION DEMONSTRATED THAT THE ARCHITECT C8000 PROCESSING MODULE IS PERFORMING WITHIN ITS INTENDED USE, LABEL CLAIMS, AND SPECIFICATIONS. NO DEFICIENCY RELATED TO THE PERFORMANCE OF THE DEVICE WAS IDENTIFIED. THIS IS A FINAL REPORT. END OF REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ELEVATED SODIUM RESULTS WERE GENERATED AND REPORTED FROM THE LABORATORY WHEN CONTROLS WERE OUT OF SPECIFICATIONS ON THE ARCHITECT C8000 ANALYZER. ONE PT GENERATED AN INITIAL RESULT OF 156 MMOL/L AND WAS ADMITTED TO INTENSIVE CARE FOR IV THERAPY (NORMAL SALINE FOR TREATMENT OF DEHYDRATION AND UTI). THE PT WAS EVENTUALLY DISCHARGED FROM THE HOSPITAL. A SERVICE CALL WAS INITIATED. THERE IS NO FURTHER IMPACT TO PT MANAGEMENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other LOT#: AA60712020| AERO.C8K ICT MODULE LIST# 9D28-03