BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 PROCESSING MODULE (INTEGRATED)

    MDR report key: 23873054 · Received December 22, 2025

    Report

    Report Number
    3016438761-2025-00757
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    December 1, 2025
    Report Date
    January 15, 2026
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740003753
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION SECTION H4 - DEVICE MFR DATE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. THE CUSTOMER OBSERVED AN ISSUE WHERE THE ARCHITECT SYSTEM REPORT DEMOGRAPHICS DID NOT MATCH THE DEMOGRAPHICS ON THE SPECIMEN BARCODE LABEL ON THE ARCHITECT C4000 INTGR, SERIAL NUMBER (B)(6). THE SEARCH FOR SIMILAR COMPLAINTS FOUND ADDITIONAL COMPLAINTS RELATED TO THE TEXT QUERY, HOWEVER, THERE HAVE BEEN NO SUBSEQUENT TICKETS OPENED FOR REPORT DEMOGRAPHICS NOT MATCHING THE DEMOGRAPHICS ON THE SPECIMEN BARCODE LABEL. REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS RELATED TO THE COMPLAINT ISSUE. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT NUMBER OR ISSUE. LABELING WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT C4000 INTGR, SERIAL NUMBER (B)(6) OR THE ARCHITECT SYSTEM SOFTWARE V9.45 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED THE ARCHITECT C4000 PRINTOUT SHOWED THE INCORRECT PATIENT DEMOGRAPHICS, WHEN COMPARED WITH INFORMATION ON BARCODE LABEL FOR A SAMPLE. THE BARCODE LABEL CONTAINS THE CORRECT PATIENT DEMOGRAPHICS. PATIENT 1: SID (B)(6) RUN (B)(6) 2025 WITH PATIENT ID (B)(6) INITIALS (B)(6) FOR IRON TEST. THIS PATIENT WAS HOSPITALIZED A MONTH AGO AND HAS NOT BEEN BACK FOR ANYTHING SINCE. PATIENT 2: CORRECT PATIENT ID (B)(6) WITH PATIENT INITIALS LL WHICH ALSO HAD AN IRON TEST CUSTOMER MANUALLY ORDERED TEST FOR CORRECT PATIENT ID (B)(6) AND REPORTED THE RESULTS WITH CORRECT DEMOGRAPHICS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED THE ARCHITECT C4000 PRINTOUT SHOWED THE INCORRECT PATIENT DEMOGRAPHICS, WHEN COMPARED WITH INFORMATION ON BARCODE LABEL FOR A SAMPLE. THE BARCODE LABEL CONTAINS THE CORRECT PATIENT DEMOGRAPHICS. PATIENT 1: SID (B)(6) RUN (B)(6) 2025 WITH PATIENT ID (B)(6) INITIALS (B)(6) FOR IRON TEST. THIS PATIENT WAS HOSPITALIZED A MONTH AGO AND HAS NOT BEEN BACK FOR ANYTHING SINCE. PATIENT 2: CORRECT PATIENT ID (B)(6) WITH PATIENT INITIALS (B)(6) WHICH ALSO HAD AN IRON TEST. CUSTOMER MANUALLY ORDERED TEST FOR CORRECT PATIENT ID (B)(6) AND REPORTED THE RESULTS WITH CORRECT DEMOGRAPHICS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1786326 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