BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000

    MDR report key: 19214758 · Received April 30, 2024

    Report

    Report Number
    3016438761-2024-00249
    Event Type
    Malfunction
    Date Received
    April 30, 2024
    Date of Event
    April 11, 2024
    Report Date
    May 22, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740003753
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 HAS BEEN INCLUDED. NO ADDITIONAL PATIENT DETAILS ARE AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE AERO C8K ICT MOD WAS DETERMINED TO BE THE CAUSE OF THE DEPRESSED RESULT. THE CUSTOMER REPLACED THE PART, AND THE ISSUE WAS RESOLVED. NO ADDITIONAL DISCREPANT RESULT ISSUES HAVE BEEN REPORTED SINCE THE PART WAS REPLACED. THE INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL SERVICE TICKETS ASSOCIATED WITH DISCREPANT/ERRATIC RESULTS. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS. ADDITIONALLY, LABELING WAS REVIEWED AND ADEQUATELY ADDRESSED THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED SODIUM RESULTS GENERATED ON THE ARCHITECT C4000 INSTRUMENT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2024 AT 1:15AM INITIAL RESULT FOR SID (B)(6) WAS 119 MMOL/L, RERUN RESULT 133 MMOL/L. SECOND DRAW WHEN PATIENT CAME IN TO ER DRAWN ON (B)() 2024 AT 3:45AM SID (B)(6) WAS 133 MMOL/L, RERUN RESULT 135 MMOL/L (NORMAL RANGE 133 - 142 MMOL/L). PATIENT HISTORICAL NA RESULTS 133 - 135 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1992919 ARCHITECT C4000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740003753

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown