BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 17824896 · Received September 27, 2023

    Report

    Report Number
    3016438761-2023-00517
    Event Type
    Malfunction
    Date Received
    September 27, 2023
    Date of Event
    September 12, 2023
    Report Date
    October 9, 2023
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137380
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED DUE TO THE CUSTOMER REPORTING FALSELY ELEVATED SODIUM (NA) RESULTS ON THE ALINITY C PROCESSING MODULE, SERIAL NUMBER (B)(6). THROUGH AN EXTENSIVE INVESTIGATION, THE FSR DETERMINED THE TBG, ICT VALVE NO TO WASTE (C-35016691-02) WAS BLOCKED, THE FSR REMOVED THE BLOCKAGE, AND THE ISSUE WAS RESOLVED. NO ADDITIONAL DISCREPANT RESULT ISSUES HAVE BEEN REPORTED SINCE THE SERVICE ACTIVITY WAS COMPLETED. THE TBG, ICT VALVE NO TO WASTE (C-35016691-02) WAS DETERMINED TO BE THE LIKELY CAUSE. A REVIEW OF THE INSTRUMENT HISTORY REVEALED NO CONTRIBUTING FACTORS DESCRIBED IN THIS COMPLAINT. A REVIEW OF LABELING AND HISTORICAL DATA WAS DONE, AND BOTH WERE ADEQUATE, WITH NO TRENDS FOUND. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED SODIUM RESULT FOR ONE PATIENT ON THE ALINITY C PROCESSING MODULE, SERIAL (B)(6). THE SAMPLE WAS REPEATED WITH HIGHER RESULT ON ANOTHER ALINITY. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT = 170 REPEAT RESULT = 139. THE NORMAL RANGE FOR SODIUM IS 133-146. CRITICAL LIMITS ARE <120 AND >150 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED SODIUM RESULT FOR ONE PATIENT ON THE ALINITY C PROCESSING MODULE, SERIAL NUMBER (B)(6). THE SAMPLE WAS REPEATED WITH HIGHER RESULT ON ANOTHER ALINITY. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT = (B)(6) REPEAT RESULT = (B)(6). THE NORMAL RANGE FOR SODIUM IS 133-146. CRITICAL LIMITS ARE <120 AND >150 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777154 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown TBG, ICT VALVE NO TO WASTE, C-35016691-02,| TBG, ICT VALVE NO TO WASTE, C-35016691-02,