BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000

    MDR report key: 20602271 · Received November 4, 2024

    Report

    Report Number
    3016438761-2024-00647
    Event Type
    Malfunction
    Date Received
    November 4, 2024
    Date of Event
    October 17, 2024
    Report Date
    November 11, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740003753
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE TO SECTION H6 - ADVERSE EVENT PROBLEM: CHANGE OF MEDICAL DEVICE PROBLEM CODE FROM A090807 TO A090809.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER INSPECTED THE ARCHITECT C4000 PROCESSING MODULE AND PERFORMED A FLUSHING OF THE ICT MODLE, WHICH RESOLVED THE ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL TICKETS ASSOCIATED WITH DISCREPANT/ERRATIC PATIENT 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 OF THE ARCHITECT C4000 DID NOT IDENTIFY ANY TRENDS ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF TRACKING AND TRENDING FOR THE ICT MODLE DID NOT IDENTIFY ANY TRENDS. 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 AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT C4000 PROCESSING MODULE FOR SERIAL (B)(6) OR THE ICT MODLE WAS IDENTIFIED.

    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.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED SODIUM ON THE ARCHITECT C4000 FOR ONE PATIENT. THE CUSTOMER HAD REPLACED THE ICT MODULE BEFORE THE DISCREPANT RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED (REFERENCE RANGE, SODIUM 136 TO 145 MMOL/L): INITIAL SODIUM RESULT= 162 MMOL/L; REPEAT RESULT= 136 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED SODIUM ON THE ARCHITECT C4000 FOR ONE PATIENT. THE CUSTOMER HAD REPLACED THE ICT MODULE BEFORE THE DISCREPANT RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED (REFERENCE RANGE, SODIUM 136 TO 145 MMOL/L): INITIAL SODIUM RESULT= 162 MMOL/L; REPEAT RESULT= 136 MMOL/L THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED SODIUM ON THE ARCHITECT C4000 FOR ONE PATIENT. THE CUSTOMER HAD REPLACED THE ICT MODULE BEFORE THE DISCREPANT RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED (REFERENCE RANGE, SODIUM 136 TO 145 MMOL/L): INITIAL SODIUM RESULT= 162 MMOL/L; REPEAT RESULT= 136 MMOL/L THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72506 ARCHITECT C4000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740003753

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ICT MODLE, 09D28-04, 240311649.