BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 3022976 · Received March 27, 2013

    Report

    Report Number
    1628664-2013-00068
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    CGZ
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. A PRODUCT EVALUATION WAS PERFORMED. THE PRODUCT LABELING WAS REVIEWED AND FOUND THE ARCHITECT SYSTEM OPERATIONS MANUAL AND THE ICT DILUENT SOLUTION PACKAGE INSERT CONTAINED ADEQUATE INFORMATION FOR THE DESCRIBED ISSUE. A REVIEW OF SERVICE HISTORY FOR SERIAL NUMBER (B)(4), FOUND NO SERVICE HISTORY ISSUES. A REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL DISCREPANT RESULT COMPLAINTS, OR COMPLAINTS FOR ICT PROBE ISSUES, FOR ARCHITECT C8000, SERIAL NUMBER (B)(4). THE CHLORIDE DISCREPANT RESULT ISSUE WAS RESOLVED THOUGH THE REPLACEMENT OF THE ICT PROBE. THE INSTRUMENT/PROBE IS MEETING PERFORMANCE SPECIFICATIONS AND PERFORMING AS INTENDED. NO SYSTEMIC DEFICIENCY OR ADVERSE TREND OF AN ICT PROBE ISSUE WAS IDENTIFIED DURING THIS INVESTIGATION, AND NO FURTHER INVESTIGATION OF THIS COMPLAINT ISSUE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ARCHITECT ANALYZER IS GENERATING ERRATIC CHLORIDE RESULTS (120 REPEAT 108 MEQ/L) ON ONE PATIENT SAMPLE. THE QUALITY CONTROL RESULTS ARE ACCEPTABLE. THE CUSTOMER WAS INSTRUCTED TO RUN ONE PATIENT SAMPLE 10 TIMES AS A REPRODUCIBILITY TEST. THE RESULTS GENERATED WERE: SODIUM 9X =109, 1X = 103; CHLORIDE 9X=137, 1X = 143. THE CUSTOMER WAS THEN INSTRUCTED TO REPLACE THE ICT PROBE ON THE ANALYZER. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125704 ARCHITECT C8000 SYSTEM CGZ ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 ICT PROBE, LIST # 09D63-03| ICT PROBE, LIST # 09D63-03