BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 PROCESSING MODULE

    MDR report key: 23136537 · Received September 24, 2025

    Report

    Report Number
    3016438761-2025-00552
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    September 5, 2025
    Report Date
    October 15, 2025
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740000509
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    DURING THE REQUESTED SITE VISIT, THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT, DETERMINED THE WORN BELLOWS SET, INCL ROD & FITTING (ROHS) (2-89055-02), THE LEAKING MANIFOLD, DEGASSER-WASH SOL.PU (ROHS) (7-93369-01) AND CLOGGED VALVE, REAGENT / SAMPLE, CKD (ROHS) (7-202518-01) ARE THE LIKELY CAUSE OF THE ISSUE. THE FSR REPLACED THE BELLOWS, CLEANED/ TIGHTENED THE OTHER PARTS AND THE ISSUES WERE RESOLVED. A REVIEW OF THE ARCHITECT C8000 SERIAL NUMBER, (B)(6) SERVICE HISTORY WAS PERFORMED AND NO ADDITIONAL DISCREPANT RESULT ISSUES HAVE BEEN REPORTED SINCE THE SERVICE ACTIVITY WAS COMPLETED. 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 HISTORICAL DATA REVEALED NO TRENDS, SYSTEMIC ISSUES, OR RELATED NONCONFORMANCES THE ARCHITECT SYSTEM OPERATIONS MANUAL PROVIDES ADEQUATE INFORMATION REGARDING THE TROUBLESHOOTING OF ERRATIC/DISCREPANT RESULTS. THE ARCHITECT C8000 SYSTEM SERVICE AND SUPPORT MANUAL PROVIDES INSTRUCTION FOR THE REMOVAL, REPLACEMENT AND VERIFICATION OF THE BELLOWS SET, INCL ROD & FITTING (ROHS) (2-89055-02), MANIFOLD, DEGASSER-WASH SOL.PU (ROHS) (7-93369-01) AND THE VALVE, REAGENT / SAMPLE, CKD (ROHS) (7-202518-01). A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR EITHER THE ARCHITECT C8000 SERIAL NUMBER, (B)(6), OR THE BELLOWS SET, INCL ROD & FITTING (ROHS), MANIFOLD, DEGASSER-WASH SOL.PU AND THE VALVE, REAGENT / SAMPLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED DISCREPANT RESULTS GENERATED FROM ARCHITECT C8000 PROCESSING MODULE FOR SEVERAL PATIENTS. THE ONE RESULT EXAMPLE PROVIDED WERE: SID (B)(6) CREATININE INITIAL=1.65 MG/DL /REPEATED ON ANOTHER ARCHITECT C8000=2.11 MG/DL LABORATORY REFERENCE RANGE FOR 0 UP TO 12YRS=0.20 TO 0.70 MG/DL; 12 YRS UP TO UNSPECIFIED FEMALE=0.50 TO 1.10 MG/DL; MALE=0.50 TO 1.30 MG/DL. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED DISCREPANT RESULTS GENERATED FROM ARCHITECT C8000 PROCESSING MODULE FOR SEVERAL PATIENTS. THE ONE RESULT EXAMPLE PROVIDED WERE: SID (B)(6) CREATININE INITIAL=1.65 MG/DL /REPEATED ON ANOTHER ARCHITECT C8000=2.11 MG/DL LABORATORY REFERENCE RANGE FOR 0 UP TO 12YRS=0.20 TO 0.70 MG/DL; 12 YRS UP TO UNSPECIFIED FEMALE=0.50 TO 1.10 MG/DL; MALE=0.50 TO 1.30 MG/DL THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2431732 ARCHITECT C8000 PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740000509

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown