BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 23830155 · Received December 17, 2025

    Report

    Report Number
    3016438761-2025-00734
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    November 27, 2025
    Report Date
    January 9, 2026
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137380
    PMA / PMN Number
    K170316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    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. SECTION A1 - PATIENT IDENTIFIER COMPLETE ENTRY = SAMPLE ID (B)(6), SAMPLE ID (B)(6), SAMPLE ID (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ALINITY C, SERIAL NUMBER (B)(6). THE FIELD SERVICE REPRESENTATIVE (FSR) DETERMINED THE CAUSE FOR THE MODULE GENERATING MESSAGE CODE 4402 OPTICS TRIGGER ERRORS AND DISCREPANT ALINITY C SODIUM RESULTS WAS THE TUBING, PERISTALTIC HEAD (ROHS). THE TUBING, PERISTALTIC HEAD (ROHS) WAS REPLACED. THE MODULE FUNCTION WAS VERIFIED WITH A CONTROL RUN. THE ISSUE WAS CONSIDERED RESOLVED WITH THE REPLACEMENT OF THE TUBING, PERISTALTIC HEAD (ROHS). THE SERVICE HISTORY OF THE (B)(6) FOUND NO ADDITIONAL DISCREPANT SODIUM RESULTS WERE REPORTED AFTER THE CURRENT EVENT WAS IDENTIFIED. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS WITH REGARDS TO THE CUSTOMER REPORTED EVENT. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED FOR THE ALINITY C INSTRUMENT OR THE TUBING, PERISTALTIC HEAD (ROHS).

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED SODIUM RESULTS FOR SEVERAL PATIENTS ON AN ALINITY C ANALYZER. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE IS 136-145 MEQ/L): SAMPLE ID (B)(4), 55-YEAR-OLD MALE, INITIAL RESULT, ON (B)(6) 2025, WAS 120, REPEAT RESULT WAS 135, CORRECTED RESULT, FROM ANOTHER ANALYZER, WAS 143, PATIENT¿S PREVIOUS RESULT, ON (B)(6), WAS 146, PATIENT¿S RESULT, ON (B)(6), WAS 142 MEQ/L SAMPLE ID (B)(6), 72-YEAR-OLD FEMALE, INITIAL RESULT, ON (B)(6) 2025, WAS 110, REPEAT RESULT WAS 139 MEQ/L SAMPLE ID (B)(6), 58-YEAR-OLD MALE, INITIAL RESULT, ON (B)(6) 2025, WAS 110, REPEAT RESULT WAS 138 MEQ/L . THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED SODIUM RESULTS FOR SEVERAL PATIENTS ON AN ALINITY C ANALYZER. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE IS 136-145 MEQ/L): SAMPLE ID (B)(6), 55-YEAR-OLD MALE, INITIAL RESULT, ON (B)(6) 2025, WAS 120, REPEAT RESULT WAS 135, CORRECTED RESULT, FROM ANOTHER ANALYZER, WAS 143, PATIENT¿S PREVIOUS RESULT, ON (B)(6), WAS 146, PATIENT¿S RESULT, ON (B)(6), WAS 142 MEQ/L . SAMPLE ID (B)(6), 72-YEAR-OLD FEMALE, INITIAL RESULT, ON (B)(6) 2025, WAS 110, REPEAT RESULT WAS 139 MEQ/L. SAMPLE ID (B)(6), 58-YEAR-OLD MALE, INITIAL RESULT, ON (B)(6) 2025, WAS 110, REPEAT RESULT WAS 138 MEQ/L . THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2039346 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown