BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 1904659 · Received November 22, 2010

    Report

    Report Number
    1628664-2010-00424
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Report Date
    November 3, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    CGZ
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IN RESPONSE TO THIS ISSUE AN INVESTIGATION WAS INITIATED TO FURTHER EXAMINE THE CUSTOMER'S OBSERVATION. THE INVESTIGATION INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF LABELING AND A REVIEW OF THE ARCHITECT C8000 SYSTEM LOGS. A REVIEW OF THE ARCHITECT C8000 SYSTEM LOGS CONFIRMED THE ELEVATED CHLORIDE RESULTS. ADDITIONALLY, A REVIEW OF THE SYSTEM MAINTENANCE LOGS REVEALED THE "FLUSH BULK SOLUTIONS" PROCEDURE HAD BEEN PERFORMED EARLY ON THE DAY THE DISCREPANT RESULTS WERE GENERATED AND AGAIN AFTER THE RESULTS WERE GENERATED. A POSSIBLE CAUSE FOR THE ISSUE IS THAT THE ICT MODULE MAY HAVE CONTAINED A BUBBLE AND/OR WAS CONTAMINATED AND THE BULK SOLUTION FLUSH MAY HAVE RESOLVED THE ISSUE. THE INSTRUMENT HISTORY LOG INDICATED AN "ICT REFERENCE SOLUTION INVENTORY LOW" ERROR WAS GENERATED, SUGGESTING THE ICT SOLUTION WAS INSTALLED JUST PRIOR TO THE DISCREPANT CHLORIDE RESULTS. A REVIEW OF COMPLAINT TRACKING AND TRENDING FOR THE PERIOD OF (B)(4) 2010 THROUGH (B)(4) 2010 DID NOT REVEAL ANY ISSUES OR ADVERSE TRENDS RELATED TO THE ICT REFERENCE SOLUTION LOT 37992UN10. PRODUCT LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS PROBABLE CAUSES AND CORRECTIONS FOR ERRATIC RESULTS, AS WELL AS, GUIDELINES CONCERNING THE AUTOMATIC PROCESSING MODULE, INCLUDING PROPER REPLACEMENT OF BULK SOLUTIONS. A REVIEW OF THE INSTRUMENT SERVICE HISTORY DID NOT REVEAL ANY ADDITIONAL COMPLAINTS FOR ELEVATED OR ERRATIC CHLORIDE RESULTS FOR ARCH C8000 (B)(4). BASED UPON THE INVESTIGATION AND THE INFORMATION AVAILABLE IT WAS DETERMINED THAT THE ARCHITECT C8000, LIST NUMBER 1G06-01, (B)(4) AND THE ICT REFERENCE SOLUTION, LOT NUMBER 37992UN10 ARE PERFORMING AS INTENDED. NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4): ICT REF SOL, LIST NUMBER 1E49-20, LOT NUMBER 37992UN10. AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. AN INVESTIGATION IS IN PROCESS.

    Description of Event or Problem · 1

    THE CUSTOMER STATED SEVERAL FALSELY ELEVATED CHLORIDE RESULTS WERE GENERATED ON THE ARCHITECT C8000 ANALYZER. THE CUSTOMER INDICATED THE ICT REFERENCE SOLUTION WAS THOUGHT TO BE THE CAUSE AS THE ISSUE OCCURRED RIGHT AFTER A NEW LOT OF SOLUTION WAS PLACED ON THE ARCHITECT. PATIENT 6 GENERATED AN INITIAL CHLORIDE OF 116 MEQ/L WITH A REPEAT OF 107 MEQ/L. THE INCORRECT RESULT WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ICT MOD, 9D28-03, ICT CHLORIDE| ICT MOD, 9D28-03, ICT CHLORIDE, ICT REF SOL