BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 24904735 · Received April 16, 2026

    Report

    Report Number
    3016438761-2026-00219
    Event Type
    Malfunction
    Date Received
    April 16, 2026
    Date of Event
    April 9, 2026
    Report Date
    April 22, 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. ALL AVAILABLE PATIENT INFORMATION HAS BEEN PROVIDED.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE ALINITY C PROCESSING MODULE, SERIAL NUMBER (B)(6), AND REPLACED THE ICT PRE AMP CABLE. THE CABLE, ICT TO ICT PRE AMP WAS DETERMINED TO BE THE CAUSE OF THE ISSUE. THE INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL SERVICE TICKETS ASSOCIATED WITH DISCREPANT/ERRATIC PATIENT RESULTS. THERE WERE NO ISSUES ON OR AROUND THE DATE THIS COMPLAINT WAS INITIATED THAT MAY HAVE CONTRIBUTED TO THE CURRENT COMPLAINT. A REVIEW OF TRENDING DATA ASSOCIATED WITH THE CABLE, ICT TO ICT PRE AMP DID NOT IDENTIFY ANY TRENDS. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE ALINITY C PROCESSING MODULE 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 THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY C PROCESSING MODULE, SERIAL NUMBER (B)(6) OR THE CABLE, ICT TO ICT PRE AMP WERE IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED SODIUM RESULTS GENERATED ON ALINITY C PROCESSING MODULE ON A PATIENT. RESULTS WERE NOT REPORTED TO MEDICAL PROVIDER. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2026; 73 YEARS MALE, SID (B)(6); INITIAL RESULT =116 MMOL/L, REPEAT RESULTS =128 & 129 MMOL/L. LABORATORY REFERENCE RANGE: 133 - 146 MMOL/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED SODIUM RESULTS GENERATED ON ALINITY C PROCESSING MODULE ON A PATIENT. RESULTS WERE NOT REPORTED TO MEDICAL PROVIDER. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2026; 73 YEARS MALE, SID (B)(6); INITIAL RESULT =116 MMOL/L, REPEAT RESULTS =128 & 129 MMOL/L. LABORATORY REFERENCE RANGE: 133 - 146 MMOL/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322162 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1