BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000

    MDR report key: 16434514 · Received February 24, 2023

    Report

    Report Number
    3016438761-2023-00097
    Event Type
    Malfunction
    Date Received
    February 24, 2023
    Date of Event
    January 16, 2023
    Report Date
    February 28, 2023
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740003753
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS ISSUE WAS PREVIOUSLY REPORTED UNDER MDR NUMBER 3002809144-2023-00072 UNDER A DIFFERENT SUSPECT DEVICE.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE ARCHITECT C4000 PROCESSING MODULE AND DETERMINED THE NOZZLE, DRY (ROHS), CUV WASH AND ASPIR TUBING BUNDLE (ROHS) AND THE HCW PUMP OUT TO T FTG (ROHS) AS THE LIKELY CAUSES. THE FSR REPLACED THE PARTS, AND THE ISSUE WAS RESOLVED. 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 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. A REVIEW OF TRACKING AND TRENDING FOR THE NOZZLE, DRY (ROHS), CUV WASH AND ASPIR TUBING BUNDLE (ROHS) AND THE HCW PUMP OUT TO T FTG (ROHS) DID NOT IDENTIFY ANY TRENDS. A REVIEW OF THE SCORECARD IDENTIFIED NO SIMILAR ISSUES RELATED TO THE ARCHITECT SYSTEM, LIKELY CAUSE PARTS, OR DISCREPANT RESULTS AS DESCRIBED. A REVIEW OF HISTORICAL DATA FOUND NO NON-CONFORMANCES RELATED TO THE CURRENT COMPLAINT. LABELING WAS REVIEWED AND PROVIDES ADEQUATE INFORMATION REGARDING THE TROUBLESHOOTING OF ERRATIC/DISCREPANT RESULTS. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY FOR THE ARCHITECT C4000 PROCESSING MODULE FOR SN (B)(6) OR THE NOZZLE, DRY (ROHS), CUV WASH AND ASPIR TUBING BUNDLE (ROHS) AND THE HCW PUMP OUT TO T FTG (ROHS) WAS IDENTIFIED. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE ELEVATED MAGNESIUM RESULT GENERATED ON ARCHITECT C4000 ANALYZER FOR ONE SAMPLE. RESULTS PROVIDED: CUSTOMER NORMAL RANGE 1.6 ¿ 2.6 MG/DL (B)(6) 2023 SID (B)(6) INITIAL RESULT 7.8 MG/DL, REPEAT RESULT ON SAME ANALYZER 1.8 MG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2058197 ARCHITECT C4000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 2P24-40 00380740003753

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown