BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 PROCESSING MODULE (INTEGRATED)

    MDR report key: 22535296 · Received July 17, 2025

    Report

    Report Number
    3016438761-2025-00416
    Event Type
    Malfunction
    Date Received
    July 17, 2025
    Date of Event
    July 6, 2025
    Report Date
    August 7, 2025
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740003753
    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

    THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED TROUBLESHOOTING ON THE INSTRUMENT, ARCHITECT C4000, SERIAL NUMBER (B)(6). SERVICE OBSERVED THAT THE HCW PUMP WAS CLOGGED/OBSTRUCTED CAUSING INADEQUATE CUVETTE WASHING. THE HCW PUMP OUT TO T FTG (ROHS)_PART NUMBER 7-205612-02 WAS DEEMED THE LIKELY CAUSE AND CLEANED (UNBLOCKED), RESOLVING THE ISSUE. THE INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL SERVICE TICKETS ON OR AROUND THE DATE THIS COMPLAINT WAS INITIATED THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. A REVIEW OF COMPLAINT AND TRENDING DATA FOR THE ARCHITECT C4000 PROCESSING MODULE DID NOT IDENTIFY AN INCREASE IN COMPLAINTS AS RELATED TO THE CURRENT COMPLAINT. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT C4000 PROCESSING MODULE, SERIAL NUMBER (B)(6) OR THE HCW PUMP OUT TO T FTG (ROHS)_PART NUMBER 7-205612-02 WAS IDENTIFIED.

    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.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY DEPRESSED TOTAL BILIRUBIN RESULT ON THE ARCHITECT C4000, SERIAL NUMBER (B)(6) FOR ONE PATIENT. THE SAMPLE WAS REPEATED ON AN ARCHITECT C8000, SERIAL NUMBER (B)(6), WITH THE EXPECTED RESULTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT = T BILI <0.10 MG/DL REPEAT RESULT = 0.28 MG/DL. REFERENCE RANGE = 0.20 - 1.20 MG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY DEPRESSED TOTAL BILIRUBIN RESULT ON THE ARCHITECT C4000, SERIAL NUMBER (B)(6) FOR ONE PATIENT. THE SAMPLE WAS REPEATED ON AN ARCHITECT C8000, SERIAL NUMBER (B)(6), WITH THE EXPECTED RESULTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT = T BILI <0.10 MG/DL REPEAT RESULT = 0.28 MG/DL. REFERENCE RANGE = 0.20 - 1.20 MG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964513 ARCHITECT C4000 PROCESSING MODULE (INTEGRATED) ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740003753

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CC TOTAL BILI (2750T), 06L45-22.