BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000

    MDR report key: 21072370 · Received January 3, 2025

    Report

    Report Number
    3016438761-2025-00007
    Event Type
    Malfunction
    Date Received
    January 3, 2025
    Date of Event
    December 15, 2024
    Report Date
    February 13, 2025
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740000509
    PMA / PMN Number
    EXEMPT
    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

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP 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

    FIELD B3 - DATE OF EVENT UPDATED FROM 17DEC2024 TO 15DEC2024. AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED DUE TO THE CUSTOMER REPORTING FALSELY ELEVATED SODIUM (NA) AND POTASSIUM (K) RESULTS ON AN ARCHITECT C8000, SERIAL NUMBER (B)(6). THROUGH AN EXTENSIVE INVESTIGATION, THE FSR FOUND THE TBG, ICT MCC POT-WARMING TUBE (ROHS), PART NUMBER 2-89533-02, CRACKED AND NEEDED TO BE REPLACED, WHICH RESOLVED THE ISSUE. NO SUBSEQUENT ISSUES HAVE BEEN REPORTED. 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 INCREASE IN COMPLAINT ACTIVITY. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED SODIUM (NA) AND POTASSIUM (K) RESULTS FOR 15 PATIENTS ON AN ARCHITECT C8000 ANALYZER. THE CUSTOMER STATED THEY WERE EXPERIENCING ERRATIC NA AND BUN QUALITY CONTROL ISSUES AFTER REPLACING THE HCW BELLOWS ON THE ANALYZER. THE FOLLOWING EXAMPLE WAS PROVIDED (CUSTOMER¿S NORMAL RANGE IS 135-146 MMOL/L): SAMPLE ID (B)(6) INITIAL NA RESULT WAS 162, REPEAT RESULT, ON ANOTHER ANALYZER, WAS 141 MMOL/L THERE WERE NO OTHER PATIENT DATA PROVIDED BY THE CUSTOMER. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED SODIUM (NA) AND POTASSIUM (K) RESULTS FOR 15 PATIENTS ON AN ARCHITECT C8000 ANALYZER. THE CUSTOMER STATED THEY WERE EXPERIENCING ERRATIC NA AND BUN QUALITY CONTROL ISSUES AFTER REPLACING THE HCW BELLOWS ON THE ANALYZER. THE FOLLOWING EXAMPLE WAS PROVIDED (CUSTOMER¿S NORMAL RANGE IS 135-146 MMOL/L): SAMPLE ID (B)(6) INITIAL NA RESULT WAS 162, REPEAT RESULT, ON ANOTHER ANALYZER, WAS 141 MMOL/L THERE WERE NO OTHER PATIENT DATA PROVIDED BY THE CUSTOMER. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639237 ARCHITECT C8000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740000509

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown