BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 22078603 · Received May 23, 2025

    Report

    Report Number
    3016438761-2025-00310
    Event Type
    Malfunction
    Date Received
    May 23, 2025
    Date of Event
    May 8, 2025
    Report Date
    June 12, 2025
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137380
    PMA / PMN Number
    K170316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE ALINITY C PROCESSING MODULE (SERIAL NUMBER (B)(6)), FOUND THE ICT WARMING RING (C-35016783-02) WAS BENT AND THE TBG, IREF CUP TO WARMING TUBE (ROHS) (7-203005-01) WAS WORN. THE FSR REPLACED THE ICT WARMING RING (C-35016783-02) AND TBG, IREF CUP TO WARMING TUBE (ROHS) (7-203005-01) TO RESOLVE THE ISSUE. NO ADDITIONAL DISCREPANT RESULT ISSUES HAVE BEEN REPORTED SINCE THE SERVICE ACTIVITY WAS COMPLETED. THE INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL SERVICE TICKETS ASSOCIATED WITH DISCREPANT/ERRATIC PATIENT 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 COMPLAINT AND TRENDING DATA FOR THE ALINITY I PROCESSING MODULE DID NOT IDENTIFY ANY SIMILAR ISSUES DESCRIBED IN THIS COMPLAINT. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY INCREASE IN COMPLAINT ACTIVITY FOR THE ICT WARMING RING OR THE TBG, IREF CUP TO WARMING TUBE (ROHS). A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ICT WARMING RING, TBG, IREF CUP TO WARMING TUBE (ROHS), OR THE ALINITY C PROCESSING MODULE, SERIAL NUMBER (B)(6).

    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 WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY ELEVATED SODIUM RESULT GENERATED ON THE ALINITY C PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED: PATIENT 2: INITIAL SODIUM RESULT = 164 MMOL/L; REPEAT ON ANOTHER ANALYZER ((B)(6)) = 138 MMOL/L THE CUSTOMER STATED THE INITIAL RESULTS DID NOT GET RELEASED TO THE MEDICAL PROVIDER. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY ELEVATED SODIUM RESULT GENERATED ON THE ALINITY C PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED: PATIENT 2: INITIAL SODIUM RESULT = 164 MMOL/L; REPEAT ON ANOTHER ANALYZER (B)(6) = 138 MMOL/L THE CUSTOMER STATED THE INITIAL RESULTS DID NOT GET RELEASED TO THE MEDICAL PROVIDER. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2321887 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ICT WARMING RING, C-35016783-02, UNKNOWN| ICT WARMING RING, C-35016783-02, UNKNOWN| TBG, IREF CUP TO WARMING TUBE (ROHS), 7-203005-01,| TBG, IREF CUP TO WARMING TUBE (ROHS), 7-203005-01,