BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    MDR report key: 24039879 · Received January 12, 2026

    Report

    Report Number
    3005094123-2026-00015
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    December 30, 2025
    Report Date
    March 23, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740186029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT, LOT 78014UD00. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. REVIEW OF TRACKING AND TRENDING BY LIST NUMBER AND BY COMPLAINT LOT DID NOT IDENTIFY ANY TRENDS. DEVICE HISTORY REVIEW DID NOT IDENTIFY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. THE OVERALL PERFORMANCE OF ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENTS IN THE FIELD WAS REVIEWED USING DATA FROM CUSTOMERS WORLDWIDE. THE PATIENT MEDIAN VALUES FOR LOTS 78011UD00 AND 78013UD00 (WHICH CONTAIN THE SAME BULK MATERIAL AS LOT 78014UD00) ARE WITHIN THE ESTABLISHED LIMITS AND COMPARABLE TO THE HISTORICAL REAGENT LOT PERFORMANCE. REVIEW OF APPLICABLE FIELD DATA SUGGESTS THAT THE PERFORMANCE IS ACCEPTABLE. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT, LOT 78014UD00.

    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. SECTION A1 PATIENT IDENTIFIER COMPLETE SID: (B)(6) ( ALL SIDS WERE FROM THE SAME PATIENT).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULT ON A 42-YEAR-OLD MALE PATIENT. ALL SID LISTED BELOW ARE FROM THE SAME PATIENT. RESULTS WERE REPORTED TO MEDICAL PROVIDER. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025, SID (B)(6), INITIAL RESULT = 223 NG/L, REPEAT RESULT ON ANOTHER PROCESSING MODULE (B)(6) = < 2 NG/L. (B)(6) 2025, SID (B)(6), RESULTS WERE = 4 NG/L & REPEAT RESULT ON ANOTHER PROCESSING MODULE (B)(6) = 3 NG/L. (B)(6) 2025, SID (B)(6) = RESULTS WERE = < 2 NG/L, (B)(6) 2025 = < 2 NG/L & < 2 NG/L AND (B)(6) 2025, RESULT ON ANOTHER PROCESSING MODULE (B)(6) = < 2 NG/L. THE CUSTOMER USES REFERENCE RANGE < 26 NG/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULT ON A 42-YEAR-OLD MALE PATIENT. ALL SID LISTED BELOW ARE FROM THE SAME PATIENT. RESULTS WERE REPORTED TO MEDICAL PROVIDER. THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2025, SID (B)(6), INITIAL RESULT = 223 NG/L, REPEAT RESULT ON ANOTHER PROCESSING MODULE (B)(6) = < 2 NG/L. ON (B)(6) 2025, SID (B)(6), RESULTS WERE = 4 NG/L & REPEAT RESULT ON ANOTHER PROCESSING MODULE (B)(6) = 3 NG/L. ON (B)(6) 2025, SID (B)(6) = RESULTS WERE = < 2 NG/L, (B)(6) 2025 = < 2 NG/L & < 2 NG/L AND (B)(6) 2025, RESULT ON ANOTHER PROCESSING MODULE (B)(6) = < 2 NG/L. THE CUSTOMER USES REFERENCE RANGE < 26 NG/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277888 ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 78014UD00 00380740186029

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male ALNTY I PROCESSING MODU, 03R65-01, (B)(6).| ALNTY I PROCESSING MODU, 03R65-01, (B)(6).