BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000

    MDR report key: 18640941 · Received February 5, 2024

    Report

    Report Number
    3016438761-2024-00069
    Event Type
    Malfunction
    Date Received
    February 5, 2024
    Date of Event
    January 17, 2024
    Report Date
    February 9, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740003753
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE: SECTION H4 - DEVICE MFG DATE UPDATED FROM BLANK TO 12/3/2011. THE CUSTOMER PERFORMED THE MANUAL CUVETTE WASHING MAINTENANCE AND DIAGNOSTIC (M&D) PROCEDURE FOR THE ARC C4 CUVT SEG WHICH RESOLVED THE ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. AN INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL ERRATIC OR DISCREPANT PATIENT RESULTS REPORTED FOR (B)(6). THERE WERE NO 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, SERIAL NUMBER (B)(6) DID NOT IDENTIFY ANY TRENDS ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF TRACKING AND TRENDING FOR THE ARC C4 CUVT SEG, DID NOT IDENTIFY ANY TRENDS. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. DEVICE HISTORY RECORD REVIEW DID NOT SHOW ANY NON-CONFORMANCES OR POTENTIAL NON-CONFORMANCES FOR THE COMPLAINT ISSUE. REVIEW OF THE ALINITY C/CLINICAL CHEMISTRY PRODUCT MONITORING REVIEW DID NOT IDENTIFY ANY SIMILAR ISSUES RELATED TO THE ARCHITECT SYSTEM. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT C4000 FOR SERIAL (B)(6), OR THE ARC C4 CUVT SEG, WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FINAL 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 MAGNESIUM RESULT GENERATED ON THE ARCHITECT C4000 FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 1.6-2.6 MG/DL): INITIAL RESULT = 9.5 MG/DL, REPEAT = 1.6 MG/DL, 1.5 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM RESULT GENERATED ON THE ARCHITECT C4000 FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 1.6-2.6 MG/DL): INITIAL RESULT = 9.5 MG/DL, REPEAT = 1.6 MG/DL, 1.5 MG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287898 ARCHITECT C4000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740003753

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CC MAGNESIUM, 03P68-21, (B)(6) | CC MAGNESIUM, 03P68-21, (B)(6)