BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 1102007 · Received August 7, 2008

    Report

    Report Number
    1628664-2008-00191
    Event Type
    Malfunction
    Date Received
    August 7, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 17, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    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

    (B)(4). FIELD SERVICE WAS DISPATCHED TO THE ACCOUNT. FIELD SERVICE RESOLVED THE ISSUE BY REPLACING MULTIPLE PARTS, OPTIMIZING THE SYSTEM, AND PERFORMING MAINTENANCE FOLLOWED BY ACCEPTABLE PERFORMANCE TESTING. FIELD SERVICE INDICATED A LIKELY CAUSE OF THE ISSUE WAS INCORRECT ALIGNMENT/AIR LEAK OF THE ICT MODULE ALONG WITH THE OTHER ITEMS THAT THEY CORRECTED. A REVIEW OF TRENDING DATA DID NOT IDENTIFY A PRODUCT ISSUE AR ADVERSE TREND. THE COMPLAINT ANALYSIS AND TRENDING SYSTEM (CATS) WAS REVIEWED AND NO ADVERSE TRENDS WERE SEEN FOR INCONSISTENT, ERRATIC AND ABERRANT RESULT COMPLAINTS. LABELING IN THE ARCHITECT OPERATIONS MANUAL PROVIDES SUFFICIENT INFORMATION WITH REGARD TO SYSTEM MAINTENANCE AND TROUBLESHOOTING THE CUSTOMER'S ISSUE. PROBABLE CAUSES AND CORRECTIVE ACTIONS FOR THE CUSTOMER'S ISSUE ARE PROVIDED UNDER THE OBSERVED PROBLEM ERRATIC RESULTS, POOR PRECISION. TROUBLESHOOTING PERFORMED TO RESOLVE THE ISSUE IS CONSISTENT WITH TROUBLE SHOOTING PROVIDED IN THE OPERATIONS MANUAL. SECTION 9, SERVICE AND MAINTENANCE, PROVIDES THE MAINTENANCE SCHEDULE AND INSTRUCTIONS FOR PERFORMING MAINTENANCE. SUBSECTION "COMPONENT REPLACEMENT" PROVIDES INSTRUCTIONS FOR REMOVING AND INSTALLING VARIOUS COMPONENTS INCLUDING THE ICT MODULE AND ITS ASSOCIATED TUBING AS WELL AS THE REAGENT AND SAMPLE PROBES AND THEIR ASSOCIATED TUBING. SECTION 9 ALSO PROVIDES A LIST OF AS-NEEDED MAINTENANCE PROCEDURES FOR TROUBLESHOOTING/DIAGNOSTICS OR DURING ROUTINE OPERATION WHEN PROBLEMS ARE OBSERVED. THE LIST INCLUDES: 6053 - PROBE WATER WASH; 6054 - PROBE ACID WASH; 6055 - DETERGENT B PROBE WASH. SECTION 10 TROUBLESHOOTING AND DIAGNOSTICS INCLUDES PROBABLE CAUSES AND CORRECTIVE ACTIONS APPLICABLE TO THE CUSTOMER'S ISSUE UNDER THE OBSERVED PROBLEMS "ERRATIC RESULTS, POOR PRECISION". MULTIPLE CAUSES ARE LISTED, INCLUDING BUT NOT LIMITED TO HARDWARE FAILURE, SCHEDULED MAINTENANCE IS DUE, SAMPLE OR REAGENT PROBE IS DAMAGED OR MISALIGNED OR PARTIALLY OBSTRUCTED, PROBE OR SYRINGE TUBING CONNECTIONS ARE LOOSE OR LEAKING, AND MANY OTHER CAUSES. THE CAUSE "HARDWARE FAILURE" INCLUDES THE FOLLOWING ITEMS LISTED: ICT ASPIRATION TUBING, ICT ASPIRATION PUMP, CUVETTE WASHER, DAQ BOARD, AND AC/DC DRIVER BOARD. FOR HARDWARE FAILURES THE CUSTOMER IS INSTRUCTED TO CALL ABBOTT CUSTOMER SUPPORT. CORRECTIVE ACTIONS FOR THE OTHER PROBABLE CAUSES INCLUDE PERFORMING MAINTENANCE, CHECKING SAMPLE INTEGRITY, CLEANING OR REPLACING COMPONENTS SUCH AS PROBES, TUBING AND SYRINGES, AND MUCH MORE. THE USER IS REFERENCED TO COMPONENT REPLACEMENT PROCEDURES IN SECTION 9 SERVICE AND MAINTENANCE. THIS IS THE FINAL REPORT. NO DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THE ARCHITECT ANALYZER GENERATED A LOW SODIUM RESULT OF 116 MMOL/L. UPON REPEATING, THE RESULT WAS 136 MMOL/L. THE INITIAL RESULT WAS NOT REPORTED. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    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