BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 23752998 · Received December 8, 2025

    Report

    Report Number
    3016438761-2025-00704
    Event Type
    Malfunction
    Date Received
    December 8, 2025
    Date of Event
    November 20, 2025
    Report Date
    February 24, 2026
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137380
    PMA / PMN Number
    K170316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A PATIENT INFORMATION: NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED. AN EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED OBSERVING FALSELY DEPRESSED SODIUM (NA) RESULTS FOR A PATIENT SAMPLE WHILE USING THE ALINITY C ICT SAMPLE DILUENT, LIST NUMBER 07P53-20, LOT NUMBER 35860UN25. THE CUSTOMER NOTED REPEATING THE PATIENT SAMPLE WITH THE SAME REAGENT LOT, WHICH GENERATED WITHIN RANGE RESULTS. THE QUALITY CONTROL (QC) RESULTS WERE WITHIN RANGE AT THE TIME OF TESTING. THE CUSTOMER PERFORMED A PRECISION RUN ON THE QC WHICH DISPLAYED ONE LOWER FLIER OF THE TEN RUN. A FSE (FIELD SERVICE ENGINEER) WENT ONSITE TO PERFORM ADDITIONAL INSTRUMENT TROUBLESHOOTING SUCH AS REPLACING THE MIXERS, WHICH RESOLVED THE QC ISSUE. A REVIEW OF COMPLAINT AND TRENDING DATA DID NOT IDENTIFY ANY TRENDS FOR THE ALINITY I PROCESSING MODULE AND THE ICT SAMPLE DILUENTWITH REGARDS TO THE CUSTOMER REPORTED EVENT. LABELING WAS REVIEWED AND WAS FOUND TO ADDRESS THE CUSTOMER REPORTED ISSUE. MANUFACTURING DOCUMENTATION FOR THE ALINITY I PROCESSING MODULE DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. BASED ON THE INFORMATION PROVIDED AND ABBOTT DIAGNOSTICS¿ COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE DEPRESSED SODIUM RESULT WHEN PROCESSING ON ALINITY C PROCESSING MODULE. ON (B)(6) 2025, ID: (B)(6) GENERATED 120 MMOL/L (REPORTED OUT OF LAB), THAT REPEATED 136 MMOL/L. THE CUSTOMER REFERENCE RANGE IS 133-146 MMOL/L. NO NEGATIVE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE DEPRESSED SODIUM RESULT WHEN PROCESSING ON ALINITY C PROCESSING MODULE. ON (B)(6) 2025, ID (B)(6) GENERATED 120 MMOL/L (REPORTED OUT OF LAB), THAT REPEATED 136 MMOL/L. THE CUSTOMER REFERENCE RANGE IS 133-146 MMOL/L. NO NEGATIVE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2727350 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male