BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000 SYSTEM

    MDR report key: 8803557 · Received July 18, 2019

    Report

    Report Number
    1628664-2019-00510
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Date of Event
    June 25, 2019
    Report Date
    July 18, 2019
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740005924
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THE FIELD SERVICE ENGINEER INVESTIGATED THE ARCHITECT (B)(4) AND OBSERVED NO PROBLEMS. A PRECISION RUN FOR SODIUM, POTASSIUM, AND CHLORIDE GENERATED ACCEPTABLE RESULTS. THE ICT MODULE REMAINED IN USE WITHOUT FURTHER CONCERN. A REVIEW OF THE SERVICE HISTORY FOR THE ARCHITECT (B)(4) VERIFIED THERE WERE NO SUBSEQUENT REPORTS OF INCONSISTENT OR ERRATIC RESULTS. FIELD SERVICE (FS) IDENTIFIED THE LIKELY CAUSE TO BE ICT MODULE SN 190109312. NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR ICT MODULE LOT 190109. A REVIEW OF HISTORICAL DATA FOR ICT MODULE LN 09D28-03 REVEALED NO ADVERSE TRENDS, SYSTEMIC ISSUES, OR NONCONFORMANCES RELATED TO ERRATIC OR INCONSISTENT SODIUM OR POTASSIUM RESULTS. TRACKING AND TRENDING DATA FOR CLINICAL CHEMISTRY SYSTEMS REVEALED THE CALCULATED ERRATIC RATES FOR THE ARCHITECT C4000, C8000, AND THE C16000 SYSTEMS WERE ALL BELOW THE UPPER CONTROL LIMIT. MANUFACTURING DOCUMENTATION WAS REVIEWED AND PROVIDES ADEQUATE LABELING REGARDING REQUIREMENTS FOR HANDLING SPECIMENS, MAINTENANCE, COMPONENT REPLACEMENT, LIMITATIONS OF RESULT INTERPRETATION, AND TROUBLESHOOTING THE ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT (B)(4) SYSTEM.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED FALSELY DEPRESSED SODIUM OF 118.3 MMOL/L ON ID (B)(6) ON (B)(6) 2019 THAT REPEATED 140.3 MMOL/L WHEN PROCESSING ON THE ARCHITECT C16000. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598375 ARCHITECT C16000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740005924

    Patients

    Seq Age Sex Outcome Treatment
    1