BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 PROCESSING MODULE (INTEGRATED)

    MDR report key: 23414334 · Received October 29, 2025

    Report

    Report Number
    3016438761-2025-00643
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Date of Event
    October 13, 2025
    Report Date
    November 25, 2025
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740003753
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ARCHITECT C4000 PROCESSING MODULE, SERIAL NUMBER (B)(6) AND THE ARCHITECT SYSTEM SOFTWARE V9.55. SAMPLE SID (B)(6) WAS FIRST RUN ON CARRIER RACK E743 (POSITION 2) FOR APOB AND GGT2 ASSAYS BUT RECEIVED EXCEPTION CODE 4200. AFTER RUNNING ANTI-HBS QC ON CARRIER E750, THE CUSTOMER RERAN THE SAMPLE, WHICH THEN APPEARED ON THE ORDER SCREEN AS BEING ON CARRIER E750 (POSITION 1) FOR APOB AND GGT2, DESPITE E750 BEING DESIGNATED FOR QC ONLY. REVIEW OF THE PROVIDED INSTRUMENT LOGS BY THE SOFTWARE TEAM DID NOT PROVIDE ANY ADDITIONAL INFORMATION TO DETERMINE THE CAUSE OF THE ISSUE BECAUSE THE LOGS DID NOT INCLUDE THE TIMEFRAME OF OCCURRENCE. THE ERROR MESSAGE 4200 HAPPENED AT 06:39AM ON 10/13/25, BUT THE RSH SAMPLE LOG STARTS AT ABOUT 08:37AM ON THAT DAY. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS WITH REGARDS TO THE CUSTOMER REPORTED EVENT. REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    COMPLETE INFORMATION FROM SECTION A1 PATIENT IDENTIFIER: SID (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION HAS BEEN INCLUDED. NO ADDITIONAL PATIENT DETAILS ARE AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 02P24-40 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 02P24, WITH 510K EXEMPT.

    Description of Event or Problem · 0

    THE CUSTOMER STATED THAT AFTER RUNNING ANTI-HBS QC ON CARRIER E750/2 (B)(6) 2025 AT 07:32), THEY PROCESSED TESTING FOR SAMPLE (SID (B)(6) FOR GGT2 AND APOB RESULTS. THE SAMPLE SID (B)(6) WAS PROCESSED (B)(6) 2025 (06:59) WITH EXCEPTION STATUS (0218 UNABLE TO PROCESS TEST, NO PROCESSING MODULES AVAILABLE) WITH CARRIER E743 BUT GENERATED INSTRUMENT ERROR MESSAGE 4200 (UNABLE TO READ BAR CODE LABEL AT CARRIER E743 POSITION 2). THE CUSTOMER RAN VITAMIN D QC ON CARRIER E750/4 (B)(6) 2025 AT 07:39), BUT IT SHOWED ORDER STATUS FOR SID (B)(6) WAS ALSO RUNNING ON E750/1. THE CUSTOMER STATED THAT THEY ONLY USE E750 FOR QC. THE CUSTOMER REPEATED THE SAMPLE SID (B)(6) ON ANOTHER CARRIER TO COMPARE RESULTS. THE FOLLOWING RESULTS WERE PROVIDED FOR SID (B)(6), APOB (REFERENCE RANGE 49 ¿ 182 MG/DL) INITIAL RESULT 79 MG/DL (B)(6) 2025 (07:16) (CARRIER E750/1), REPEATED 84 MG/DL (B)(6) 2025 (07:45) (CARRIER E742/1). GGT2 INITIAL RESULT 57 U/L (B)(6) 2025 (07:16) (CARRIER E750/1). REPEATED 30 U/L (B)(6) 2025 (07:32) (CARRIER E742/1). THE MISMATCH RESULTS WERE THE ANTI-HBS NEGATIVE QC WAS SENT TO THE LIS AS SAMPLE RESULT FOR APOB AND GGT2. THE CUSTOMER MANUALLY ORDERED FOR ANTI-HBS QC ON CARRIER E750 POSITION 1-2 AND VITAMIN D QC ON CARRIER E750 POSITION 3-4 (B)(6) 2025 AT 07:39). THE PATIENT SAMPLE SID (B)(6) WAS PROCESSED (B)(6) 2025 (06:59) WITH EXCEPTION STATUS (0218 UNABLE TO PROCESS TEST, NO PROCESSING MODULES AVAILABLE) WITH CARRIER E743 BUT GENERATED INSTRUMENT ERROR MESSAGE 4200 (UNABLE TO READ BAR CODE LABEL AT CARRIER E743 POSITION 2). THE CUSTOMER RERAN 4 PATIENT SAMPLES FROM EXCEPTION STATUS USING CARRIER E743. ON SCREEN IT DISPLAYED SID (B)(6) WAS PENDING STATUS AND THE OTHER 3 SAMPLES SCHEDULE THEN RUNNING. AFTER CARRIER E750 READ BY RSH THEY SAW SID (B)(6) NOW CHANGE FROM PENDING TO SCHEDULE AND RUNNING FOR APOB AND GGT AS ORDERED BEFORE. THE CUSTOMER STATED THAT CARRIER E750 IS ALWAYS USED FOR THE QC RUN. AFTER THE CUSTOMER REALIZED THAT THE SAMPLE MAY HAVE BEEN MISMATCHED WITH THE QC, THEY REPEATED SID (B)(6) FOR GGT AND APOB. THE FOLLOWING RESULTS WERE PROVIDED FOR SID (B)(6); APOB (REFERENCE RANGE 49 ¿ 182 MG/DL) INITIAL RESULT 79 MG/DL (B)(6) 2025 (07:16) (CARRIER E750/1), REPEATED 84 MG/DL (B)(6) 2025 (07:45) (CARRIER E742/1). GGT2 INITIAL RESULT 57 U/L (B)(6) 2025 (07:16) (CARRIER E750/1). REPEATED 30 U/L (B)(6) 2025 (07:32) (CARRIER E742/1). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER STATED THAT AFTER RUNNING ANTI-HBS QC ON CARRIER E750/2 (B)(6) 2025 AT 07:32), THEY PROCESSED TESTING FOR SAMPLE (SID (B)(6) FOR GGT2 AND APOB RESULTS. THE SAMPLE SID (B)(6) WAS PROCESSED (B)(6) 2025 (06:59) WITH EXCEPTION STATUS (0218 UNABLE TO PROCESS TEST, NO PROCESSING MODULES AVAILABLE) WITH CARRIER E743 BUT GENERATED INSTRUMENT ERROR MESSAGE 4200 (UNABLE TO READ BAR CODE LABEL AT CARRIER E743 POSITION 2). THE CUSTOMER RAN VITAMIN D QC ON CARRIER E750/4 (B)(6) 2025 AT 07:39), BUT IT SHOWED ORDER STATUS FOR SID (B)(6) WAS ALSO RUNNING ON E750/1. THE CUSTOMER STATED THAT THEY ONLY USE E750 FOR QC. THE CUSTOMER REPEATED THE SAMPLE SID (B)(6) ON ANOTHER CARRIER TO COMPARE RESULTS. THE FOLLOWING RESULTS WERE PROVIDED FOR SID (B)(6): APOB (REFERENCE RANGE 49 ¿ 182 MG/DL) INITIAL RESULT 79 MG/DL (B)(6) 2025 (07:16) (CARRIER E750/1), REPEATED 84 MG/DL (B)(6) 2025 (07:45) (CARRIER E742/1). GGT2 INITIAL RESULT 57 U/L (B)(6) 2025 (07:16) (CARRIER E750/1). REPEATED 30 U/L (B)(6) 2025 (07:32) (CARRIER E742/1). THE MISMATCH RESULTS WERE THE ANTI-HBS NEGATIVE QC WAS SENT TO THE LIS AS SAMPLE RESULT FOR APOB AND GGT2. THE CUSTOMER MANUALLY ORDERED FOR ANTI-HBS QC ON CARRIER E750 POSITION 1-2 AND VITAMIN D QC ON CARRIER E750 POSITION 3-4 (B)(6) 2025 AT 07:39). THE PATIENT SAMPLE SID (B)(6) WAS PROCESSED (B)(6) 2025 (06:59) WITH EXCEPTION STATUS (0218 UNABLE TO PROCESS TEST, NO PROCESSING MODULES AVAILABLE) WITH CARRIER E743 BUT GENERATED INSTRUMENT ERROR MESSAGE 4200 (UNABLE TO READ BAR CODE LABEL AT CARRIER E743 POSITION 2). THE CUSTOMER RERAN 4 PATIENT SAMPLES FROM EXCEPTION STATUS USING CARRIER E743. ON SCREEN IT DISPLAYED SID (B)(6) WAS PENDING STATUS AND THE OTHER 3 SAMPLES SCHEDULE THEN RUNNING. AFTER CARRIER E750 READ BY RSH THEY SAW SID (B)(6) NOW CHANGE FROM PENDING TO SCHEDULE AND RUNNING FOR APOB AND GGT AS ORDERED BEFORE. THE CUSTOMER STATED THAT CARRIER E750 IS ALWAYS USED FOR THE QC RUN. AFTER THE CUSTOMER REALIZED THAT THE SAMPLE MAY HAVE BEEN MISMATCHED WITH THE QC, THEY REPEATED SID (B)(6) FOR GGT AND APOB. THE FOLLOWING RESULTS WERE PROVIDED FOR SID (B)(6): APOB (REFERENCE RANGE 49 ¿ 182 MG/DL) INITIAL RESULT 79 MG/DL (B)(6) 2025 (07:16) (CARRIER E750/1), REPEATED 84 MG/DL (B)(6) 2025 (07:45) (CARRIER E742/1). GGT2 INITIAL RESULT 57 U/L (B)(6) 2025 (07:16) (CARRIER E750/1). REPEATED 30 U/L (B)(6) 2025 (07:32) (CARRIER E742/1). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224508 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