BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000

    MDR report key: 1048325 · Received May 20, 2008

    Report

    Report Number
    1628664-2008-00130
    Event Type
    Malfunction
    Date Received
    May 20, 2008
    Date of Event
    April 25, 2008
    Report Date
    April 25, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (ISSUE RESOLVED THROUGH TROUBLESHOOTING. NO DEFINITE CAUSE FOR THE LOW PHOSPHORUS RESULTS). THE CUSTOMER OBSERVED LOW PHOSPHORUS RESULTS FOR PT SAMPLES. IN ORDER TO RESOLVE THE ISSUE, THE CUSTOMER REPLACED THE PHOSPHORUS REAGENT CARTRIDGE ON THE INSTRUMENT; HOWEVER, THE NEW REAGENT CARTRIDGE DID NOT RESOLVE THE ISSUE. THE CUSTOMER TECHNICAL ADVOCATE (CTA) INSTRUCTED THE CUSTOMER TO PERFORM A SERIES OF TROUBLESHOOTING STEPS. THE CUSTOMER PERFORMED THE RECOMMENDED TROUBLESHOOTING. NO INSTRUMENT PARTS WERE REPLACED; HOWEVER, THE CUSTOMER DID TIGHTEN THE CONNECTIONS AROUND THE TUBING AND STYLETTED THE CUVETTE WASHER NOZZLES. THE CUSTOMER STATED AFTER THE COMPLETION OF TROUBLESHOOTING, THERE HAVE BEEN NO OTHER OCCURRENCES OF PHOSPHORUS RESULTS LESS THAN 0.5 MG/DL. THE CONTROLS HAVE BEEN IN RANGE AND THE INSTRUMENT IS PERFORMING WITHIN SPECS. A REVIEW OF THE COMPLAINT HISTORY FOR THE ARCHITECT CSYSTEM OVER THE TIME PERIOD OF 2007 THROUGH 2008 WAS PERFORMED. THE REVIEW DID NOT FIND OTHER COMPLAINTS RELATED TO THIS ISSUE. THE ARCHITECT SYSTEM OPERATIONS MANUAL (PN 201837-104 2007) INDICATES THE FOLLOWING RELATED TO THE CUSTOMER ISSUE: SECTION 9: SERVICE MAINTENANCE MONTHLY MAINTENANCE DESCRIPTION (C SYSTEM PREOCESSING MODULE). MONTHLY MAINTENANCE FOR THE C SYSTEM IS REQUIRED ON THE PROCESSING MODULE ONLY. PERFORM THESE PROCEDURES MONTHLY: 6016 CHECK DISPENSE COMPONENTS, PAGE 9-27, 6018 CLEAN CUVETTE WASHER NOZZLES, PAGE 9-27, 6026 CHECK SYRINGES AND VALVES, PAGE 9-28, 6300 CLEAN ICT DRAIN TIP, PAGE 9-28. SECTION 10: TROUBLESHOOTING AND DIAGNOSTICS, UNDER THE OBSERVED PROBLEMS - ERRATIC RESULTS, POOR PRECISION - PHOTOMETRIC RESULTS (C SYSTEM) AND CONTROLS OUT OF RANGE (C-SYSTEM) SECTIONS, TWO TABLES OF PROBABLE CAUSES AND CORRECTIVE ACTIONS HAVE BEEN PROVIDED FOR THE CUSTOMER TO TROUBLESHOOT THEIR SYSTEM. CONCLUSION: ALTHOUGH THERE IS NOT DEFINITE CAUSE FOR THE LOW PHOSPHORUS RESULTS, THE ISSUE APPEARS TO BE RESOLVED BY TIGHTENING TUBING CONNECTIONS AND CLEANING THE CUVETTE WASHER NOZZLES, WHICH IS PART OF MONTHLY MAINTENANCE. THIS IS A FINAL REPORT. END OF REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE ARCHITECT C8000 ANALYZER GENERATED PHOSPHORUS RESULTS OF LESS THAN 0.5 MG/DL FOR PTS. WHEN REPEATED, THE RESULTS WERE BETWEEN 5.0 MG/DL AND 6.0 MG/DL. THE CUSTOMER OBSERVED THE SAME PHENOMENON ON AT LEAST ONE CONTROL VALUE. THE LOW PHOSPHORUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF IMPACT TO THE PT MANAGEMENT.

    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 NI CC PHOSPHORUS