BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000 SYSTEM

    MDR report key: 8794688 · Received July 16, 2019

    Report

    Report Number
    1628664-2019-00501
    Event Type
    Malfunction
    Date Received
    July 16, 2019
    Report Date
    August 6, 2019
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740005924
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE SUBSEQUENT SITE VISIT, THE ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) FOUND THAT THE WASH PRESSURE FOR R1A AND B WERE BELOW SPECIFICATIONS. THE FSR REPLACED THE BELLOWS, BELLOWS ONLY, PART NUMBER 2-89054-02, TO RESOLVE THE ISSUE. AFTER THE R1 WASH PRESSURE WAS DETERMINED TO BE WITHIN SPECIFICATION THE FSR RAN ICT PRECISION AND QC WITH RESULTS WITHIN SPECIFICATIONS. NO ADDITIONAL DISCREPANT RESULTS WERE REPORTED ON THE ARCHITECT SERIAL NUMBER (SN) (B)(6) AFTER THE PART WAS REPLACED. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE ARCHITECT C1600298 INSTRUMENT SERVICE HISTORY REVEALED NO ADDITIONAL ERRATIC OR DISCREPANT PATIENT RESULTS REPORTED. THERE WERE NO SERVICE OR COMPLAINT ISSUES ON OR AROUND THE DATE THIS COMPLAINT WAS INITIATED THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. THE MONTHLY PRODUCT MONITORING REVIEW FOR THE C16000 SYSTEMS WAS REVIEWED AND NO SYSTEMIC ISSUES OR TRENDS FOR ERRATIC/DISCREPANT RESULTS WAS IDENTIFIED. A REVIEW OF HISTORICAL DATA FOR THE BELLOWS, BELLOWS ONLY (ROHS), PART NUMBER 2-89054-02 FOUND NO TRENDS OR SYSTEMIC ISSUES. THE ARCHITECT SYSTEM OPERATIONS MANUAL AND THE ARCHITECT C16000 SERVICE AND SUPPORT MANUAL, PROVIDE ADEQUATE INFORMATION, TROUBLESHOOTING, AND MAINTENANCE CONCERNING ERRATIC / DISCREPANT RESULTS. INCLUDING, BUT NOT LIMITED TO, THE TROUBLESHOOTING PERFORMED BY THE FIELD SERVICE REPRESENTATIVE (REPLACING THE BELLOWS AND THE POPPET VALVES). BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT, SN (B)(6) OR THE BELLOWS, BELLOWS ONLY (ROHS) PN 2-89054-02.

    Additional Manufacturer Narrative · 1

    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 REPORTED FALSELY ELEVATED SODIUM (NA) RESULTS ON A PATIENT GENERATED ON THE ARCHITECT ANALYZER. THE RESULTS PROVIDED WERE GENERATED BETWEEN 24JUN2019 THRU 26JUN2019: NA INITIAL WAS 160 AND REPEATED AS NORMAL. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589488 ARCHITECT C16000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740005924

    Patients

    Seq Age Sex Outcome Treatment
    1 CONCENTRATED ICT DILUENT, LN 02P32-11| CONCENTRATED ICT DILUENT, LN 02P32-11| LOT # UNKNOWN| LOT # UNKNOWN - SODIUM| CONCENTRATED ICT DILUENT, LN 02P32-11| LOT # UNKNOWN - SODIUM