BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 21596605 · Received March 13, 2025

    Report

    Report Number
    3016438761-2025-00154
    Event Type
    Malfunction
    Date Received
    March 13, 2025
    Date of Event
    February 24, 2025
    Report Date
    April 1, 2025
    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 FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT AND RESOLVED THE ISSUE BY CLEARING A CLOG FROM THE ALNTY CI EXTERNAL WASTE FEMALE CONNECTOR. NO ADDITIONAL DISCREPANT RESULT ISSUES HAVE BEEN REPORTED SINCE THE SERVICE ACTIVITY WAS COMPLETED. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE INSTRUMENT SERVICE HISTORY REVIEW FOR (B)(6) REVEALED NO ADDITIONAL SERVICE TICKETS ASSOCIATED WITH DISCREPANT/ERRATIC RESULTS. THERE WERE NO ADDITIONAL SERVICE OR COMPLAINT ISSUES ON OR AROUND THE DATE THIS COMPLAINT WAS INITIATED THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. A REVIEW OF TRACKING AND TRENDING FOR THE ALINITY C-SERIES PROCESSING MODULE DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. A REVIEW OF TRACKING AND TRENDING FOR THE ALNTY CI EXTERNAL WASTE DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY C-SERIES PROCESSING MODULE FOR SERIAL (B)(6) OR THE ALNTY CI EXTERNAL WASTE WERE IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED SODIUM RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 133-146): SID (B)(6) INITIAL RESULT 119 MMOL/L, REPEATED 134 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED SODIUM RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 133-146): SID (B)(6) INITIAL RESULT 119 MMOL/L, REPEATED 134 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804299 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown