BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 PROCESSING MODULE (INTEGRATED)

    MDR report key: 21900757 · Received April 24, 2025

    Report

    Report Number
    3016438761-2025-00246
    Event Type
    Malfunction
    Date Received
    April 24, 2025
    Date of Event
    April 8, 2025
    Report Date
    May 5, 2025
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740003753
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) RESOLVED THE ISSUE BY REPLACING THE TUBING FROM THE ASPIRATION PUMP 14 TO THE T-FITTING. NO ADDITIONAL DISCREPANT RESULT ISSUES HAVE BEEN REPORTED SINCE THE PART WAS REPLACED. PART NUMBER 7-205558-02 TBG, ASP PUMP 14 TO T FTG (ROHS) WAS DETERMINED TO BE THE LIKELY CAUSE OF THE ISSUE. THE INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL SERVICE TICKETS ASSOCIATED WITH DISCREPANT/ERRATIC ICT PATIENT 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 OF THE CLINICAL CHEMISTRY SYSTEMS DID NOT IDENTIFY ANY SIMILAR ISSUES RELATED TO THE ARCHITECT C4000 PROCESSING MODULE, OR THE PART NUMBER 7-205558-02 TBG, ASP PUMP 14 TO T FTG (ROHS) OR DISCREPANT RESULTS AS DESCRIBED IN THIS COMPLAINT. THE DEVICE HISTORY RECORDS WERE REVIEWED, AND NO NON-CONFORMANCES OR POTENTIAL NON-CONFORMANCES WERE IDENTIFIED. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT C4000 PROCESSING MODULE, SERIAL NUMBER (B)(6), OR THE PART NUMBER 7-205558-02 TBG, ASP PUMP 14 TO T FTG (ROHS) WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED SODIUM RESULTS ON THE ARCHITECT C4000 PROCESSING MODULE FOR ONE PATIENT. THE SAMPLE WAS REPEATED WITH HIGHER RESULTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6), INITIAL RESULT = 115 MMOL/L REPEATED ON THE ISTAT = 138 REPEATED ON THE GEM = 138 NEW SAMPLE SAME PATIENT PROCESSED ON THE ARCHITECT = 133 MMOL/L. REFERENCE RANGE = 135-145 MMOL/L THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED SODIUM RESULTS ON THE ARCHITECT C4000 PROCESSING MODULE FOR ONE PATIENT. THE SAMPLE WAS REPEATED WITH HIGHER RESULTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT = 115 MMOL/L REPEATED ON THE ISTAT = 138 REPEATED ON THE GEM = 138 NEW SAMPLE SAME PATIENT PROCESSED ON THE ARCHITECT = 133 MMOL/L. REFERENCE RANGE = 135-145 MMOL/L THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1275975 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 CONC ICT DILUENT, 02P32-11, (B)(6)| CONC ICT DILUENT, 02P32-11, (B)(6)| TBG, ASP PUMP 14 TO T FTG (ROHS), 7-205558-02, UNK| TBG, ASP PUMP 14 TO T FTG (ROHS), 7-205558-02, UNK