BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000

    MDR report key: 19806435 · Received July 23, 2024

    Report

    Report Number
    3016438761-2024-00416
    Event Type
    Malfunction
    Date Received
    July 23, 2024
    Date of Event
    June 29, 2024
    Report Date
    July 24, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740003753
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED DUE TO THE CUSTOMER REPORTING FALSELY DECREASED TOTAL BILIRUBIN (TBILI) RESULTS ON THE ARCHITECT C4000 PROCESSING MODULE, SERIAL NUMBER (B)(6). THROUGH AN EXTENSIVE INVESTIGATION, THE FSR FOUND THE BD., CRASH SENSOR REAGENT PIPETTOR (ROHS), PART NUMBER 7-93251-04, AND THE ROLLER GUIDE, RGT CRSL (ROHS), PART NUMBER 7-205320-02, NEEDED TO BE REPLACED, WHICH RESOLVED THE CUSTOMER¿S COMPLAINT. THERE HAVE BEEN NO FURTHER REPORTS OF DISCREPANT RESULTS REPORTED BY THE CUSTOMER SINCE THE CURRENT COMPLAINT. A REVIEW OF THE INSTRUMENT HISTORY REVEALED NO CONTRIBUTING FACTORS DESCRIBED IN THIS COMPLAINT. A REVIEW OF LABELING AND HISTORICAL DATA WAS DONE, AND BOTH WERE ADEQUATE, WITH NO TRENDS FOUND. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A1 - PATIENT IDENTIFIER COMPLETE ENTRY = SAMPLE ID (B)(6) AND SAMPLE ID (B)(6) ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED TOTAL BILIRUBIN RESULTS FOR TWO PATIENTS ON AN ARCHITECT C4000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE IS 0.2-1.2 MG/DL): SAMPLE ID (B)(6) INITIAL RESULT WAS <0.10, REPEAT RESULT WAS 3.05 MG/DL. SAMPLE ID (B)(6) INITIAL RESULT WAS <0.10, REPEAT RESULTS WERE 6.73 AND 6.72 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED TOTAL BILIRUBIN RESULTS FOR TWO PATIENTS ON AN ARCHITECT C4000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE IS 0.2-1.2 MG/DL): SAMPLE ID (B)(6) INITIAL RESULT WAS <0.10, REPEAT RESULT WAS 3.05 MG/DL SAMPLE ID (B)(6) INITIAL RESULT WAS <0.10, REPEAT RESULTS WERE 6.73 AND 6.72 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046404 ARCHITECT C4000 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, (B)(6) | CC TOTAL BILI (2750T), 06L45-22, (B)(6)