BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000

    MDR report key: 20156306 · Received September 6, 2024

    Report

    Report Number
    3016438761-2024-00523
    Event Type
    Malfunction
    Date Received
    September 6, 2024
    Date of Event
    August 29, 2024
    Report Date
    September 18, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740005924
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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

    THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE ARCHITECT C16000 PROCESSING MODULE AND FOUND CUVETTE 52 WAS DAMAGED. THE FSR REPLACED THE PART, AND THE ISSUE WAS RESOLVED. THE AERO CUV SEG WAS DETERMINED TO BE THE LIKELY CAUSE. NO ADDITIONAL DISCREPANT RESULTS HAVE BEEN REPORTED SINCE PART REPLACEMENT. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WAS REVIEWED. THE INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL TICKETS ASSOCIATED WITH DISCREPANT/ERRATIC 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 DID NOT IDENTIFY ANY TRENDS FOR THE AERO CUV SEG OR THE ARCHITECT C16000 PROCESSING MODULE. REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT C16000 PROCESSING MODULE FOR SERIAL NUMBER (B)(6) WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE ELEVATED MAGNESIUM RESULT GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE FOR ONE SAMPLE. THE FOLLOWING RESULTS WERE PROVIDED: (CUSTOMER PROVIDED REFERENCE RANGE 0.7-1.1 MMOL/L). ON (B)(6) 2024 INITIAL RESULT = > 2.5 MMOL/L, REPEAT RESULT 0.99 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE ELEVATED MAGNESIUM RESULT GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE FOR ONE SAMPLE. THE FOLLOWING RESULTS WERE PROVIDED: (CUSTOMER PROVIDED REFERENCE RANGE 0.7-1.1 MMOL/L). (B)(6) 2024 INITIAL RESULT = > 2.5 MMOL/L, REPEAT RESULT 0.99 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1886768 ARCHITECT C16000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740005924

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown