BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 23958699 · Received January 5, 2026

    Report

    Report Number
    3016438761-2026-00004
    Event Type
    Malfunction
    Date Received
    January 5, 2026
    Date of Event
    December 24, 2025
    Report Date
    February 16, 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

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

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSELY DECREASED SODIUM RESULTS WHILE USING ALINITY C ICT SAMPLE DILUENT, LOT NUMBER 83287UN25, ON AN ALINITY C PROCESSING MODULE, SERIAL NUMBER (B)(6), INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, AND DEVICE HISTORY RECORD REVIEW. THE CUSTOMER RETESTED THE SAMPLE USING THE SAME LOT OF REAGENT, AND ON A DIFFERENT ANALYZER, AND WITHIN RANGE RESULTS WERE GENERATED. IN ADDITION, THE QUALITY CONTROL WAS PERFORMING WITHIN THE EXPECTED RANGES. NO SUBSEQUENT ISSUES HAVE BEEN REPORTED. A REVIEW OF THE INSTRUMENT HISTORY REVEALED NO CONTRIBUTING FACTORS DESCRIBED IN THIS COMPLAINT. MANUFACTURING DOCUMENTATION WAS REVIEWED AND DID NOT IDENTIFY ANY ISSUES. A REVIEW OF LABELING AND HISTORICAL DATA WAS DONE, AND BOTH WERE ADEQUATE, WITH NO INCREASE IN COMPLAINT ACTIVITY. 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 DEPRESSED SODIUM RESULTS WHEN PROCESSING ON ALINITY C PROCESSING MODULE. 3004753838-2026-002787 ON (B)(6) 2025, SID (B)(6) (74-YEAR-OLD, FEMALE) GENERATED SODIUM OF 119 MMOL/L (NOT REPORTED), REPEATED 133 AND 135 MMOL/L. THE CUSTOMER SODIUM REFERENCE RANGE IS 133-146 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED DEPRESSED SODIUM RESULTS WHEN PROCESSING ON ALINITY C PROCESSING MODULE. ON (B)(6) 2025, SID (B)(6) (74-YEAR-OLD, FEMALE) GENERATED SODIUM OF 119 MMOL/L (NOT REPORTED), REPEATED 133 AND 135 MMOL/L. THE CUSTOMER SODIUM REFERENCE RANGE IS 133-146 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29775 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female ALNTY C ICT SAMPLE DILU, 07P53-20, (B)(6)| ALNTY C ICT SAMPLE DILU, 07P53-20, (B)(6)