BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 1297645 · Received January 30, 2009

    Report

    Report Number
    1628664-2009-00051
    Event Type
    Malfunction
    Date Received
    January 30, 2009
    Date of Event
    January 12, 2009
    Report Date
    January 21, 2009
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT INDICATES SODIUM IMPRECISION CONTINUED AFTER BLEACHING THE INTEGRATED CHIP TECHNOLOGY (ICT) AA80902066 MODULE IN 2009, WHICH DID RESOLVE IMPRECISION FOR POTASSIUM AND CHLORIDE. HOWEVER, CUSTOMER PROVIDED DATA VERIFIES OCCASIONAL INCONSISTENT (ERRATIC) RESULTS FOR SODIUM, POTASSIUM AND CHLORIDE CONTINUED AFTER BLEACHING THE MODULE THE FOLLOWING MONTH. ADDITIONAL TROUBLESHOOTING AFTER BLEACHING INCLUDED REPLACING THE ICT DILUENT (ICTD), THE IREF SOLUTION, ICT VALVES, ALL ICT 1 ML SYRINGES AND THE ICT PROBE, BUT THE INCONSISTENT RESULTS CONTINUED. THE ISSUE WAS RESOLVED TWO DAYS LATER BY REPLACING ICT MODULE AA80902066. THE CUSTOMER RETURNED SYSTEM LOGS WERE NOT HELPFUL IN VERIFYING THE ISSUE OR DETERMINING CAUSE. THE COMPLAINT HISTORY FOR THE CUSTOMER'S ARCHITECT C8000 ANALYZER (C800285) FOUND NO RECURRENCE OF THE ISSUE.A REVIEW OF COMPLAINT AND TRENDING DATA DID NOT IDENTIFY AN ADVERSE TREND OR KNOWN ISSUE FOR THE ICT MODULE RELATED TO THIS COMPLAINT ISSUE. THE REVIEW ALSO DETERMINED THAT THE CURRENT RATE OF INCONSISTENT, ERRATIC, AND ABERRANT COMPLAINTS AND OCCURRENCES IS BELOW THE ESTABLISHED LIMITS FOR THE ARCHITECT CLINICAL CHEMISTRY SYSTEMS. LABELING IN THE ARCHITECT OPERATIONS MANUAL (PN 201837-105, MAY 2008) AND ICT PACKAGE INSERT IS SUFFICIENT WITH REGARD TO THE CUSTOMER'S ISSUE. NUMEROUS PROBABLE CAUSES AND CORRECTIVE ACTIONS FOR THE CUSTOMER'S ISSUE ARE FOUND UNDER THE OBSERVED PROBLEM ERRATIC RESULTS, POOR PRECISION. BASED ON THE AVAILABLE INFORMATION AND INVESTIGATION PERFORMED, A SPECIFIC CAUSE FOR THE OCCASIONAL INCONSISTENT ICT RESULTS COULD NOT BE DETERMINED AND A DEFICIENCY WAS NOT IDENTIFIED. PROBABLE CAUSES INCLUDE SAMPLE INTEGRITY ISSUES AND/OR A PROBLEM WITH THE ICT MODULE SUCH AS CONTAMINATION THAT WAS NOT RESOLVED BY BLEACHING. TROUBLESHOOTING PERFORMED TO RESOLVE THE ISSUE IS CONSISTENT WITH THE OPERATIONS MANUAL. THE INVESTIGATION DID NOT IDENTIFY A DEFICIENCY. THIS IS A 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 IS CONCERNED WITH THE IMPRECISION SEEN WITH ELECTROLYTE RESULTS ON THE ARCHITECT C8000 ANALYZER. ONE PATIENT GENERATED THE FOLLOWING CHLORIDE ASSAY RESULTS: 8307, 99.5, 99.5 AND 98.7 MMOL/L. 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.

    Patients

    Seq Age Sex Outcome Treatment
    1 AERO/C8K ICT MOD LN:9D28-03