BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 8931784 · Received August 26, 2019

    Report

    Report Number
    1628664-2019-00585
    Event Type
    Malfunction
    Date Received
    August 26, 2019
    Report Date
    September 13, 2019
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740000509
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS PERFORMED FOR THE CUSTOMER ISSUE AND INCLUDED A REVIEW OF COMPLAINT TEXT, TROUBLESHOOTING, A REVIEW OF SERVICE HISTORY, AND A REVIEW OF PRODUCT LABELING. ABBOTT SUPPORT INSPECTED AND CALIBRATED ICT AND R1 PROBE. THE FIELD SERVICE REPRESENTATIVE (FSR) REPLACED THE ICT CABLE, THE ICT TUBING FROM THE ICT MODULE TO THE 1ML SYRINGE AND THE ICT TUBING FROM WASTE TO THE 1 ML SYRINGE. ISSUE RESOLVED AFTER REPLACEMENT OF THE ICT TUBING, PN 7-93269-0. A REVIEW OF THE (B)(4) SERVICE HISTORY SHOWS NO ADDITIONAL INCONSISTENT OR ERRATIC RESULTS SINCE FSR ADDRESSED THE ISSUE. A REVIEW OF HISTORICAL DATA FOR THE REPLACEMENT PART REVEALED NO TRENDS, SYSTEMIC ISSUES, OR RELATED NONCONFORMANCES. REVIEW OF THE ARCHITECT C8000 ANALYZER PRODUCT MONITORING DID NOT IDENTIFY ANY SIMILAR ISSUES OR TRENDS. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. NO SYSTEMIC ISSUES WERE IDENTIFIED. BASED ON ALL AVAILABLE INFORMATION A PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    COMPLETE INFORMATION PATIENT INFORMATION, PATIENT IDENTIFIER: MULTIPLE = (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY ELEVATED SODIUM RESULTS ON THE ARCHITECT C8000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED (MMOL/L): SID (B)(6) INITIAL 161.9, REPEATS 126.9, 136.8, SID (B)(6) INITIAL 163.3, REPEAT 137.9. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723108 ARCHITECT C8000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740000509

    Patients

    Seq Age Sex Outcome Treatment
    1 CONCENTRATED ICT DILUENT, LN 02P32-11| CONCENTRATED ICT DILUENT, LN 02P32-11| LOT 94974UN19| LOT 94974UN19