BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 16969924 · Received May 19, 2023

    Report

    Report Number
    3016438761-2023-00274
    Event Type
    Malfunction
    Date Received
    May 19, 2023
    Date of Event
    May 13, 2023
    Report Date
    July 7, 2023
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137380
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE ALINITY C PROCESSING MODULE, SERIAL NUMBER (B)(6), AND OBSERVED THE TBG, DIST PANEL - HCW QUICK CONNECT FTG WAS CLOGGED. THE FSR RESOLVED THE ISSUE BY REMOVING THE CLOG. THE TBG, DIST PANEL - HCW QUICK CONNECT FTG ((B)(6)) WAS DETERMINED TO BE THE LIKELY CAUSE OF THE ISSUE. NO ADDITIONAL DISCREPANT RESULT ISSUES HAVE BEEN REPORTED SINCE THE SERVICE ACTIVITY WAS COMPLETED. THE INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL SERVICE 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 DID NOT IDENTIFY ANY RELATED TRENDS FOR TBG, DIST PANEL - HCW QUICK CONNECT FTG AND ALINITY SYSTEM. NO SIMILAR ISSUES RELATED TO THE ALINITY SYSTEM WERE IDENTIFIED. A DEVICE HISTORY RECORD WAS REVIEWED AND DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS FOR THE PART AND INSTRUMENT ASSOCIATED WITH THE COMPLAINT. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE TBG, DIST PANEL - HCW QUICK CONNECT FTG AND ALINITY C PROCESSING MODULE, SERIAL NUMBER (B)(6).

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM (MG) RESULT WHEN RUNNING ON THE ALINITY C PROCESSING MODULE. THE CUSTOMER REPEATED ON ANOTHER ANALYZER AND PROVIDED THE FOLLOWING RESULTS: ON (B)(6) 2023 SID (B)(6): INITIAL RESULT = 8.0 MG/DL; REPEAT RESULT = 2.1 MG/DL (REFERENCE RANGE FOR MG: 1.6 TO 2.6 MG/DL) THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM (MG) RESULT WHEN RUNNING ON THE ALINITY C PROCESSING MODULE. THE CUSTOMER REPEATED ON ANOTHER ANALYZER AND PROVIDED THE FOLLOWING RESULTS: ON (B)(6) 2023 SID (B)(6): INITIAL RESULT = 8.0 MG/DL; REPEAT RESULT = 2.1 MG/DL (REFERENCE RANGE FOR MG: 1.6 TO 2.6 MG/DL) THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887157 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 03R6701 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ALNTY C MAGNESIUM 720T, (B)(6).| ALNTY C MAGNESIUM 720T, (B)(6).