BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 23122215 · Received September 23, 2025

    Report

    Report Number
    3016438761-2025-00550
    Event Type
    Malfunction
    Date Received
    September 23, 2025
    Date of Event
    September 5, 2025
    Report Date
    October 1, 2025
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    PMA / PMN Number
    K170316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A1 PATIENT IDENTIFIER COMPLETE INFORMATION: (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION IN SECTION D10 CONCOMITANT PRODUCT. THE FIELD SERVICE REPRESENTATIVE REPLACED MULTIPLE PARTS OF THE ALINITY C PROCESSING MODULE, INCLUDING THE REAGENT SYRINGE ASSEMBLY; HOWEVER, SERVICE DETERMINED THE REAGENT SYRINGE ASSEMBLY THE CAUSE OF THE ISSUE AND REPLACING THE REAGENT SYRINGE ASSEMBLY WAS THE ISSUE RESOLUTION. THE ALINITY C PROCESSING MODULE FUNCTION WAS VERIFIED WITH A CONTROL/PRECISION RUN. THE INSTRUMENT SERVICE HISTORY FOR THE ALINITY C PROCESSING MODULE SERIAL NUMBER (B)(6) FOUND NO ADDITIONAL DISCREPANT RESULTS REPORTED AFTER THE CURRENT EVENT WAS IDENTIFIED. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A REVIEW OF COMPLAINT AND TRENDING DATA FOR THE ALINITY C PROCESSING MODULE DID NOT IDENTIFY ANY SIMILAR ISSUES RELATED TO THE CURRENT ISSUE. ADDITIONALLY REVIEW OF COMPLAINT AND TRENDING DATA ASSOCIATED WITH THE REAGENT SYRINGE ASSEMBLY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY NON-CONFORMANCES OR POTENTIAL NON-CONFORMANCES. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY C PROCESSING MODULE FOR SERIAL NUMBER (B)(6) OR REAGENT SYRINGE ASSEMBLY WAS IDENTIFIED. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED SODIUM RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE FOR MULTIPLE SAMPLES. THE FOLLOWING RESULTS WERE PROVIDED: SID: (B)(6) INITIAL SODIUM RESULT = 118.4 MEQ/L, REPEAT RESULT = 141 MEQ/L. SID: (B)(6) INITIAL SODIUM RESULT = 119.4 MEQ/L, REPEAT RESULT = 142 MEQ/L. SID: (B)(6) INITIAL SODIUM RESULT = 119.3 MEQ/L, REPAT RESULT = 141 MEQ/L. SID: (B)(6) INITIAL SODIUM RESULT = 116.3 MEQ/L, REPEAT RESULT = 137 MEQ/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED SODIUM RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE FOR MULTIPLE SAMPLES. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) INITIAL SODIUM RESULT = 118.4 MEQ/L, REPEAT RESULT = 141 MEQ/L. SID (B)(6) INITIAL SODIUM RESULT = 119.4 MEQ/L, REPEAT RESULT = 142 MEQ/L. SID (B)(6) INITIAL SODIUM RESULT = 119.3 MEQ/L, REPEAT RESULT = 141 MEQ/L. SID (B)(6) INITIAL SODIUM RESULT = 116.3 MEQ/L, REPEAT RESULT = 137 MEQ/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532616 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY C REAGENT PROBE, 04S49-01, UNKNOWN.| REAGENT SYRINGE ASSEMBLY, C-35016393-02, UNKNOWN.| REAGENT SYRINGE ASSEMBLY, C-35016393-02, UNKNOWN.