BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    MDR report key: 23716922 · Received December 4, 2025

    Report

    Report Number
    3005094123-2025-00616
    Event Type
    Malfunction
    Date Received
    December 4, 2025
    Date of Event
    September 29, 2025
    Report Date
    January 15, 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

    AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. COMPLETED INFORMATION FOR SECTIONS A1 - PATIENT IDENTIFIER/A2 - AGE AT TIME OF EVENT/A2 - AGE UNITS (PATIENT)/A3A - SEX: SAMPLE ID (B)(6)/86/YEARS/FEMALE, SAMPLE ID (B)(6)/23/YEARS/FEMALE, SAMPLE ID (B)(6)/50/YEARS/FEMALE, SAMPLE ID (B)(6)/37/YEARS/FEMALE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P13, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 04Z21, WITH 510K/PMA/BLA NUMBER K202525.

    Additional Manufacturer Narrative · 0

    DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. A REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT DID NOT IDENTIFY ANY TRENDS RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, NO TRENDS WERE IDENTIFIED FOR LOT 77409UD00. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT NUMBER OR ISSUE. THE OVERALL PERFORMANCE OF THE ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE REVIEW OF FIELD DATA FOR LOTS 77408UD00 AND 77406UD00, WHICH CONTAINS THE SAME BULK MATERIAL AS COMPLAINT LOT 77409UD00 DETERMINED THE MEDIAN PATIENT RESULTS ARE WITHIN THE ESTABLISHED LIMITS AND COMPARABLE TO THE HISTORICAL REAGENT LOT PERFORMANCE. LABELING WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED FOR THE ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT, LOT NUMBER 77409UD00.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULTS GENERATED FOR FEMALE PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE - FEMALE <16 NG/L; MALE <26 NG/L): SAMPLE ID (B)(6), (86-YEAR-OLD) (B)(6) 2025, INITIAL RESULT ON (B)(6) = 60 NG/L, REPEAT RESULT = 2 NG/L (<3 NG/L), NEW SAMPLE OBTAINED AND RESULT = <3 NG/L. SAMPLE ID (B)(6), (23-YEAR-OLD) (B)(6) 2025, INITIAL RESULT ON (B)(6) = 93 NG/L, (B)(6) 2025 SAMPLE ID (B)(6) RESULT ON (B)(6) = 2 NG/L (<3 NG/L). SAMPLE ID (B)(6), (50-YEAR-OLD) (B)(6) 2025 INITIAL RESULT ON (B)(6) = 41 NG/L, REPEAT RESULT = (<3 NG/L), NEW SAMPLE OBTAINED SAMPLE ID (B)(6), RESULT ON (B)(6) = 0 NG/L (<3 NG/L), 3RD SAMPLE OBTAINED AND RESULT = <3 NG/L. SAMPLE ID (B)(6), (37-YEAR-OLD) (B)(6) 2025, INITIAL RESULT ON (B)(6) = 121 NG/L, REPEAT RESULT = <3 NG/L, (B)(6) 2025 NEW SAMPLE OBTAINED SAMPLE ID(B)(6), RESULT ON (B)(6) = 0 NG/L (<3 NG/L) . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULTS GENERATED FOR FEMALE PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE - FEMALE <16 NG/L; MALE <26 NG/L): SAMPLE ID (B)(6) (86-YEAR-OLD) (B)(6) 2025 INITIAL RESULT ON (B)(6) = 60 NG/L, REPEAT RESULT = 2 NG/L (<3 NG/L), NEW SAMPLE OBTAINED AND RESULT = <3 NG/L SAMPLE ID (B)(6) (23-YEAR-OLD) (B)(6) 2025 INITIAL RESULT ON (B)(6) = 93 NG/L, (B)(6) 2025 SAMPLE ID (B)(6) RESULT ON (B)(6) = 2 NG/L (<3 NG/L). SAMPLE ID (B)(6) (50-YEAR-OLD) (B)(6) 2025 INITIAL RESULT ON (B)(6) = 41 NG/L, REPEAT RESULT = (<3 NG/L), NEW SAMPLE OBTAINED SAMPLE ID (B)(6) RESULT ON AI30171 = 0 NG/L (<3 NG/L), 3RD SAMPLE OBTAINED AND RESULT = <3 NG/L. SAMPLE ID M(B)(6) (37-YEAR-OLD) (B)(6) 2025 INITIAL RESULT ON (B)(6) = 121 NG/L, REPEAT RESULT = <3 NG/L, (B)(6) 2025 NEW SAMPLE OBTAINED SAMPLE ID (B)(6) RESULT ON (B)(6) = 0 NG/L (<3 NG/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2807800 ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 77409UD00 00380740186029

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)