BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 ANALYZER

    MDR report key: 9869551 · Received March 23, 2020

    Report

    Report Number
    3016438761-2020-00009
    Event Type
    Malfunction
    Date Received
    March 23, 2020
    Date of Event
    February 27, 2020
    Report Date
    March 23, 2020
    Manufacturer
    ABBOTT LABORATORIES (IRVING IA/CC)
    Product Code
    JJE
    UDI-DI
    00380740003753
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED TROUBLESHOOTING AND REPLACED THE DAQ BOARD WHICH RESOLVED THE ISSUE. A REVIEW OF THE ANALYZER SERVICE HISTORY, FOR SERIAL (B)(4) REVEALED NO ADDITIONAL SERVICE OR COMPLAINT TICKETS ON OR AROUND THE DATE THIS COMPLAINT WAS INITIATED THAT MAY HAVE CONTRIBUTED TO THE ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF TRACKING AND TRENDING FOR THE DAQ BOARD DID NOT IDENTIFY ANY TRENDS. A REVIEW OF THE CLINICAL CHEMISTRY SYSTEMS TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE ISSUES ASSOCIATE WITH THIS COMPLAINT. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT C4000 PROCESSING MODULE OR THE DAQ BOARD WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY ELEVATED CHLORIDE RESULTS GENERATED ON THE ARCHITECT C4000 PROCESSING MODULE AFTER THE ICT MODULE WAS REPLACED. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT = 144, REPEAT = 99. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329695 ARCHITECT C4000 ANALYZER AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT LABORATORIES (IRVING IA/CC) 2P24-40 00380740003753

    Patients

    Seq Age Sex Outcome Treatment
    1