BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000

    MDR report key: 16337062 · Received February 9, 2023

    Report

    Report Number
    3016438761-2023-00070
    Event Type
    Malfunction
    Date Received
    February 9, 2023
    Date of Event
    January 16, 2023
    Report Date
    February 28, 2023
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740003746
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT, PERFORMED MULTIPLE TROUBLESHOOTING PROCEDURES, AND FOUND A SMALL HOLE IN THE WARMING RING, WATER BATH, C4 (ROHS). THE FSR REPLACED THE PART, AND THE ISSUE WAS RESOLVED. THE WARMING RING, WATER BATH, C4 (ROHS) WAS DETERMINED TO BE THE CAUSE OF THE ISSUE. NO ADDITIONAL DISCREPANT RESULT ISSUES HAVE BEEN REPORTED SINCE THE SERVICE ACTIVITY WAS COMPLETED. THE INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL SERVICE TICKETS ASSOCIATED WITH DISCREPANT/ERRATIC PATIENT RESULTS. THERE WERE NO ADDITIONAL SERVICE OR COMPLAINT ISSUES ON OR AROUND THE DATE THIS COMPLAINT WAS INITIATED THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE UNDER REVIEW. THE ARCHITECT C4000 ERRATIC RESULT RATES WERE WITHIN ACCEPTABLE LIMITS WITH NO TRENDS IDENTIFIED. LABELING REVIEW CONCLUDES THAT THE ISSUE IS ADEQUATELY ADDRESSED. BASED ON THE INVESTIGATION, NO DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED SODIUM RESULTS GENERATED ON THE ARCHITECT C4000 PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (LAB REFERENCE RANGE FOR PATIENT: 136-145 CRITICAL LOW 120): INITIAL RESULT WAS 158 MEQ/L AND THE RERUNS WERE 130, 122, 134, 125, 131, 137, 125, 120, 153, 134, 125. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1343118 ARCHITECT C4000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 2P24-01 00380740003746

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown