BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    MDR report key: 22643012 · Received July 29, 2025

    Report

    Report Number
    3005094123-2025-00370
    Event Type
    Malfunction
    Date Received
    July 29, 2025
    Date of Event
    July 9, 2025
    Report Date
    July 29, 2025
    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

    SECTION A1 PATIENT IDENTIFIER COMPLETE SID: (B)(6). THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND FIELD DATA REVIEW. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I STAT HIGH SENSITIVE TROPONIN-I ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT. THE OVERALL PERFORMANCE OF ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE PATIENT MEDIAN VALUE FOR LOT 72463UD00 IS WITHIN THE ESTABLISHED LIMITS AND COMPARABLE TO THE HISTORICAL REAGENT LOT PERFORMANCE. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY OF THE ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT LOT 72463UD00 WAS IDENTIFIED. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P13 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4Z21, WITH 510K/PMA/BLA NUMBER K202525.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULT ON A PATIENT. RESULTS PROVIDED: (B)(6) 2025,SID (B)(6) = 549.9 NG/L (LOT# 72463UD00), REPEATED SAMPLE ON (B)(6) 2025 = 6.9 / 5.9 NG/L; CUSTOMER REFERENCE RANGE: <16 NG/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887481 ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 72463UD00 00380740186029

    Patients

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