BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 24046169 · Received January 12, 2026

    Report

    Report Number
    3016438761-2026-00025
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    December 24, 2025
    Report Date
    February 26, 2026
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137380
    PMA / PMN Number
    K170316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPLACED THE MIXER. THE MIXER WAS DEEMED THE CAUSE OF THE DISCREPANT CHLORIDE RESULT. THE MODULE FUNCTION WAS VERIFIED WITH A CONTROL/PRECISION RUN. THE SERVICE HISTORY OF THE (B)(6) VERIFIES NO SUBSEQUENT ISSUES HAVE BEEN REPORTED RELATED TO DISCREPANT CHLORIDE PATIENT RESULTS AFTER THE CURRENT ISSUE WAS IDENTIFIED. A REVIEW OF TRACKING AND TRENDING OF THE MIXER AND ALINITY C PROCESSING MODULE DID NOT IDENTIFY ANY TRENDS ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE MIXER OR THE ALINITY C PROCESSING MODULE, SERIAL NUMBER (B)(6), WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED CHLORIDE GENERATED FROM ALINITY C PROCESSING MODULE. THE CUSTOMER NOTED THIS WHEN THEY REPORTED A LEAK WITH THE ALINITY C PROCESSING MODULE AND PROVIDED THE FOLLOWING DATA: SAMPLE ID (B)(6), INITIAL RESULT WAS >144.0 AND REPEAT RESULT WAS 107.0 MMOL/L (CUSTOMER REFERENCE RANGE IS 100 - 109 MMOL/L) PATIENT INFORMATION: 66-YEAR-OLD MALE. PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED CHLORIDE GENERATED FROM ALINITY C PROCESSING MODULE. THE CUSTOMER NOTED THIS WHEN THEY REPORTED A LEAK WITH THE ALINITY C PROCESSING MODULE AND PROVIDED THE FOLLOWING DATA: SAMPLE ID (B)(6), INITIAL RESULT WAS >144.0 AND REPEAT RESULT WAS 107.0 MMOL/L (CUSTOMER REFERENCE RANGE IS 100 - 109 MMOL/L) PATIENT INFORMATION: 66-YEAR-OLD MALE. PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101243 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male