BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000

    MDR report key: 11961133 · Received June 8, 2021

    Report

    Report Number
    3016438761-2021-00210
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Date of Event
    May 20, 2021
    Report Date
    June 16, 2021
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740003746
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLETE INFORMATION FOR PATIENT INFORMATION, PATIENT IDENTIFIER = SID= (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE ANALYZER AND DETERMINED THE TBG ACD WASH SOL. BOTTLE-VALVE WITH CAP (ROHS) (2-89405-03) WAS DAMAGED AND TWISTED, WHICH MAY HAVE CAUSED INADEQUATE WASHING OF THE CUVETTES. SERVICE REPLACED THE PART AND WASHED THE CUVETTES, RESOLVING THE ISSUE. THE TBG ACD WASH SOL. BOTTLE-VALVE WITH CAP (ROHS) (2-89405-03) WAS THE LIKELY CAUSE OF THE ELEVATED POTASSIUM RESULTS AND REPLACED OF THE HE TBG ACD WASH SOL. BOTTLE-VALVE WITH CAP (ROHS) (2-89405-03) RESOLVED THE ISSUE. A REVIEW OF THE ARCHITECT C PROCESSING MODULE, SERIAL NUMBER (B)(6) SERVICE HISTORY FOUND NO CONTRIBUTING FACTORS ON OR AROUND THE DATE OF THE COMPLAINT. A REVIEW OF HISTORICAL DATA REVEALED NO TRENDS, SYSTEMIC ISSUES, OR RELATED NON-CONFORMANCES. A REVIEW OF THE ARCHITECT C460905 SERVICE HISTORY WAS PERFORMED AND NO ADDITIONAL ERRATIC RESULTS PRE- OR POST THE CURRENT COMPLAINT WERE IDENTIFIED. A REVIEW OF HISTORICAL DATA FOR THE PART TBG ACD WASH SOL. BOTTLE-VALVE WITH CAP (ROHS) (2-89405-03) REVEALED NO TRENDS OR SYSTEMIC ISSUES. THE ARCHITECT SYSTEM OPERATIONS MANUAL ADDRESSES OPERATIONAL PRECAUTIONS AND LIMITATIONS AND PROVIDES PROBABLE CAUSES AND CORRECTIVE ACTIONS FOR THE TROUBLESHOOTING OF ELEVATED CONCENTRATION AND ERRATIC RESULTS. THE ARCHITECT C4000 SYSTEMS SERVICE AND SUPPORT MANUAL PROVIDES REMOVAL AND REPLACEMENT PROCEDURES FOR THE TBG ACD WASH SOL. BOTTLE-VALVE WITH CAP (ROHS) (2-89405-03). A REVIEW OF LABELLING ADEQUATELY ADDRESSES SAMPLE RESULTS OBSERVED PROBLEMS FOR ERRATIC/DISCREPANT RESULTS. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT C PROCESSING MODULE, SERIAL NUMBER (B)(6).

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED POTASSIUM RESULTS ON ARCHITECT C4000 PROCESSING MODULE FOR MULTIPLE PATIENTS. THE RESULTS PROVIDED WERE: SID (B)(6) INITIAL=6.5 MMOL/L /REPEATED=4.3 MMOL/L. SID (B)(6) INITIAL=8.4 MMOL/L /REPEATED=3.9 MMOL/L. SID (B)(6) INITIAL=9.7 MMOL/L /REPEATED=4.3 MMOL/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857223 ARCHITECT C4000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 2P24-01 00380740003746

    Patients

    Seq Age Sex Outcome Treatment
    1