BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I PROCESSING MODULE

    MDR report key: 23761429 · Received December 9, 2025

    Report

    Report Number
    3016438761-2025-00711
    Event Type
    Malfunction
    Date Received
    December 9, 2025
    Date of Event
    November 17, 2025
    Report Date
    January 5, 2026
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137366
    PMA / PMN Number
    K170317
    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

    THIS ISSUE WAS PREVIOUSLY REPORTED UNDER MDR NUMBER 3005094123-2025-00637-01 UNDER A DIFFERENT SUSPECT DEVICE. THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT AND OBSERVED BUFFER SALT BUILD UP ON THE 100UL BUFFER PUMP AND ALINITY I PROBE TUB WASH. THE FSR REPLACED THE PARTS, RESOLVING THE ISSUE. A REVIEW OF INSTRUMENT SERVICE HISTORY FOR AI24131 REVEALED THAT NO ADDITIONAL DISCREPANT RESULT ISSUES HAVE BEEN REPORTED SINCE THE SERVICE ACTIVITY WAS COMPLETED. A REVIEW OF COMPLAINT AND TRENDING DATA FOR THE ALINITY I PROCESSING MODULE DID NOT IDENTIFY ANY SIMILAR ISSUES AS DESCRIBED IN THIS COMPLAINT. ADDITIONALLY, A REVIEW OF COMPLAINT AND TRENDING DATA ASSOCIATED WITH THE 100UL BUFFER PUMP AND ALINITY I PROBE TUB WASH DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO NON-CONFORMANCES OR POTENTIAL NON-CONFORMANCES WERE IDENTIFIED. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED FOR THE ALINITY I PROCESSING MODULE, SERIAL NUMBER AI24131, THE 100UL BUFFER PUMP, OR THE ALINITY I PROBE TUB WASH.

    Additional Manufacturer Narrative · 0

    SECTION A PATIENT INFORMATION: NO ADDITIONAL PATIENT INFORMATION IS AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE ELEVATED ALINITY I STAT HIGH SENSITIVITY TROPONIN-I RESULTS WHEN PROCESSING ON THE ALINITY I PROCESSING MODULE. (B)(6) 2025, INITIAL SAMPLE, SID (B)(6) AT 1805 RESULTED 87.7 NG/L, BUT REPEATED <2.7 NG/L. (B)(6) 2025 SECOND SAMPLE, SID (B)(6) AT 1914 RESULTED <2.7 NG/L. THE CUSTOMER REFERENCE RANGE IS <2.7-14 NG/L FOR FEMALES. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE ELEVATED ALINITY I STAT HIGH SENSITIVITY TROPONIN-I RESULTS WHEN PROCESSING ON THE ALINITY I PROCESSING MODULE. 17NOV2025, INITIAL SAMPLE, SID (B)(6) AT 1805 RESULTED 87.7 NG/L, BUT REPEATED <2.7 NG/L. 17NOV2025 SECOND SAMPLE, SID (B)(6) AT 1914 RESULTED <2.7 NG/L. THE CUSTOMER REFERENCE RANGE IS <2.7-14 NG/L FOR FEMALES. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2604006 ALINITY I PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137366

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALIN I HS TNI 1200T US, 04Z21-35, (B)(6).