BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 1180404 · Received October 1, 2008

    Report

    Report Number
    1628664-2008-00225
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 5, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TUBING; ACID WASH BOTTLE TO VALVE AND ALKALINE WASH BOTTLE TO VALVE. AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED TO THE CUSTOMER AND UPON EXAMINING, THE ANALYZER FOUND THE ALKALINE AND ACID WASH BULK SOLUTIONS BOTTLE TO VALVE WASH TUBINGS WERE CRIMPED. THE FSR REPLACED THE CRIMPED TUBING AND INCREASED THE MIXER WASH WATER VOLUME TO SPECIFICATIONS. THE FSR PERFORMED A CUVETTE WASH AND RAN QUALITY CONTROL, WHICH GENERATED RESULTS WITHIN THE CUSTOMERS ESTABLISHED RANGES. A REVIEW OF THE COMPLAINT HISTORY FOR ARCHITECT CSYSTEM WAS PERFORMED OVER THE TIME PERIOD IN 2008. NO ADDITIONAL COMPLAINTS OF THIS NATURE HAVE BEEN DOCUMENTED AGAINST ARCHITECT SINCE THE FSR REPLACED THE CRIMPED ALKALINE AND ACID WASH BULK SOLUTIONS BOTTLE TO VALVE WASH TUBING AND INCREASED THE MIXER WASH WATER VOLUME TO SPECIFICATIONS. THE CURRENT COMBINED ERRATIC RESULT RATE FOR AEROSET FALLS BELOW THE ESTABLISHED AEROSET ALERT RATE AND THE C8000 AND C16000 INTERNAL ABERRANT RESULT RATES AT PRODUCT LAUNCH. THE ABBOTT ARCHITECT SYSTEM OPERATIONS MANUAL PROVIDES THE FOLLOWING INFORMATION RELATED TO ADDRESSING THE CUSTOMER ISSUE: SECTION 10, TROUBLESHOOTING AND DIAGNOSTICS, OBSERVED PROBLEMS, ERRATIC RESULTS, POOR PRECISION - PHOTOMETRIC RESULTS (C SYSTEM) LISTS MULTIPLE PROBABLE CAUSES AND CORRECTIVE ACTIONS FOR ERRATIC RESULTS. CAUSES LISTED INCLUDE, HARDWARE FAILURE, SUCH AS A MIXER MALFUNCTION, AND/OR A CUVETTE WASH MALFUNCTION. THE CORRECTIVE ACTION FOR THESE CAUSES IS TO CONTACT YOUR AREA CUSTOMER SUPPORT TO RESOLVE ANY HARDWARE FAILURE. THIS IS THE FINAL REPORT.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER STATED A PATIENT GENERATED A CREATININE RESULT OF 2.3 MG/DL ON THE ARCHITECT C8000 ANALYZER. DUE TO A PHYSICIAN QUESTIONING A HIGH CREATININE RESULT GENERATED THE SAME DAY ON A DIFFERENT PATIENT, SEVERAL PATIENT SAMPLES WERE RETESTED THREE DAYS LATER. THE SAMPLE THAT INITIALLY GENERATED A RESULT OF 2.3 MG/DL YIELDED A RESULT OF 1.6 MG/DL UPON RETEST. A CORRECTED REPORT WAS ISSUED. NO IMPACT TO PATIENT MANAGEMENT WAS 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 CC CREATININE REAGENT LIST #7D64-20 LOT # UNK