BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 ANALYZER

    MDR report key: 10543706 · Received September 16, 2020

    Report

    Report Number
    3016438761-2020-00223
    Event Type
    Malfunction
    Date Received
    September 16, 2020
    Date of Event
    September 10, 2020
    Report Date
    November 18, 2020
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740003753
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPLACED THE ICT DILUENT, ICT DETERGENT AND OPENED FRESH CALIBRATORS BUT THE ISSUE CONTINUED. THE CUSTOMER REPLACED THE ICT MODULE AND THE INSTRUMENT FUNCTIONED AS INTENDED. NO ADDITIONAL DISCREPANT RESULT ISSUES HAVE BEEN REPORTED SINCE THE ICT MODULE WAS REPLACED. A REVIEW OF INSTRUMENT SERVICE HISTORY IDENTIFIED NO CONTRIBUTING FACTORS TO THE CURRENT COMPLAINT, NOR DID IT IDENTIFY ANY SERVICE OR COMPLAINT ISSUES THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. TRACKING AND TRENDING REVIEW DID NOT IDENTIFY A TREND OR SYSTEMIC ISSUE FOR THE ICT MODULE OR THE ARCHITECT C4000. THE CALCULATED ERRATIC RATES FOR THE ARCHITECT C4000, C8000, AND THE C16000 SYSTEMS WERE ALL BELOW THE UPPER CONTROL LIMIT. THE ARCHITECT SYSTEM OPERATIONS MANUAL PROVIDES ADEQUATE INFORMATION REGARDING THE TROUBLESHOOTING OF ERRATIC/DISCREPANT ICT RESULTS AND THE REMOVAL, REPLACEMENT AND VERIFICATION OF THE ICT MODULE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION HAS BEEN INCLUDED. NO ADDITIONAL PATIENT DETAILS ARE AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY ELEVATED SODIUM RESULTS GENERATED ON THE ARCHITECT C4000 INSTRUMENT. THE RESULTS PROVIDED WERE: SID (B)(6) SODIUM INITIAL = 169 MMOL/L, REPEATED ON ANOTHER INSTRUMENT = 139 MMOL/L; (CUSTOMER PROVIDED SODIUM NORMAL RANGE: 136-145 MMOL/L). THROUGH TROUBLESHOOTING, THE ICT DILUENT AND ICT DETERGENT WERE REPLACED WITH A NEW PREPARATION AND SID: (B)(6) WAS REPEATED AND GENERATED RESULTS OF 141 / 141 / 141 / 141 /142 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004179 ARCHITECT C4000 ANALYZER AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT LABORATORIES 2P24-40 00380740003753

    Patients

    Seq Age Sex Outcome Treatment
    1