BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 1183443 · Received October 3, 2008

    Report

    Report Number
    1628664-2008-00230
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Date of Event
    September 30, 2008
    Report Date
    September 30, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED TO THIS CUSTOMER SITE AND FOUND THAT THE INTEGRATED CHIP TECHNOLOGY (ICT) MODULE TUBING WAS KINKED NEAR THE ICT REFERENCE PUMP AND THE FSR TRIMMED THE KINKED END OF THE TUBING AND RECONNECTED THE TUBING. IN 2008, THE CUSTOMER REQUESTED THAT THE FSR BE DISPATCHED BACK TO THE SITE BECAUSE ERRONEOUS PATIENT RESULTS FOR SODIUM HAD BEEN REPORTED. THE FSR REPLACED THE ICT PREAMP BOARD, ICT ASPIRATION PUMP VALVE, ICT TUBINGS AND THE CABLE FROM THE ICT PREAMP BOARD TO THE ICT. MAINTENANCE AND DIAGNOSTIC (M&D) PROCEDURES WERE PERFORMED AND PASSED. SUBSEQUENT INSTRUMENT OPERATIONS AND TEST RESULTS WERE ACCEPTABLE. THE CUSTOMER'S ISSUE IS ADDRESSED IN THE ABBOTT ARCHITECT SYSTEM OPERATIONS MANUAL (JUNE, 2007) UNDER SECTION 7, OPERATIONAL PRECAUTIONS AND LIMITATIONS - LIMITATIONS OF RESULT INTERPRETATION: ASSAY RESULTS MUST BE USED WITH OTHER CLINICAL DATA, FOR EXAMPLE, SYMPTOMS, OTHER TEST RESULTS, PATIENT HISTORY, CLINICAL IMPRESSIONS, INFORMATION AVAILABLE FROM CLINICAL EVALUATION, AND OTHER DIAGNOSTIC PROCEDURES. ALL DATA MUST BE CONSIDERED FOR PATIENT CARE MANAGEMENT. IF ASSAY RESULTS ARE INCONSISTENT WITH CLINICAL EVIDENCE, ADDITIONAL TESTING IS SUGGESTED TO CONFIRM THE RESULT. THE ARCHITECT SYSTEM HAS BEEN VALIDATED FOR ITS INTENDED USE. HOWEVER, ERRORS CAN OCCUR DUE TO POTENTIAL OPERATOR ERRORS AND ARCHITECT SYSTEM TECHNOLOGY LIMITATIONS. ALSO, SECTION 10, TROUBLESHOOTING AND DIAGNOSTICS, OBSERVED PROBLEMS, ERRATIC RESULTS, POOR PRECISION - ICT RESULTS (C SYSTEM), LISTS THE PROBABLE CAUSES AND CORRECTIVE ACTIONS FOR ERRONEOUS RESULTS. CAUSES INCLUDE ICT ASPIRATION TUBING IS NOT CONNECTED CORRECTLY, HARDWARE FAILURES SUCH AS THE ICT ASPIRATION TUBING OR THE ICT ASPIRATION PUMP, 1 ML SYRINGES IN THE ICT ASPIRATION PUMP OR IN THE ICT REFERENCE SOLUTION PUMP ARE NOT SEATED CORRECTLY. A MALFUNCTION OF THE SYSTEM WAS IDENTIFIED. BASED ON A REVIEW OF THE INSTRUMENT?S SERVICE HISTORY RECORD, SINCE THE FSR REPLACED THE SYRINGE DRIVE WITH NEW GROOVED PLATE, THE CUSTOMER HAS NOT REPORTED ANY ADDITIONAL COMPLAINTS OF THIS NATURE. NO ADVERSE TRENDS WERE IDENTIFIED RELATED TO THE ISSUE, AND A REVIEW OF THE INSTRUMENT'S SERVICE HISTORY DID NOT DETECT ANY REPEATS OF THE ISSUE SINCE THE FSR REPLACED THE SYRINGE DRIVE WITH A NEW GROOVED PLATE. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE ARCHITECT C8000 ANALYZER HAS BEEN GENERATING ERRATIC SODIUM PATIENT RESULTS AND THEY HAVE BEEN RUNNING CONTROLS EVERY HOUR TO VERIFY RESULTS. DURING A ONE HOUR PERIOD, THE OPERATOR DID NOT REALIZE THAT CONTROLS HAD READ OUT OF SPECIFICATIONS AND INCORRECT RESULTS WERE REPORTED OUT OF THE LAB. THE CUSTOMER ONLY PROVIDED ONE EXAMPLE FROM THE INCORRECT RESULTS REPORTED WHEN THE CONTROL WAS OUT OF SPECIFICATION: AN INITIAL RESULT OF 107 MMOL/L THAT RETESTED AT 144 MMOL/L. THERE IS NO REPORT OF ANY INJURY OR HARM TO ANY PATIENTS. A SERVICE CALL WAS INITIATED. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI ARCH C8000 SYSTEM LN:1G06-01