BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    MDR report key: 23117730 · Received September 22, 2025

    Report

    Report Number
    3005094123-2025-00466
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    August 29, 2025
    Report Date
    September 22, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A1 - PATIENT IDENTIFIER COMPLETE ENTRY = (B)(6). 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 (ALINITY I STAT HIGH SENSITIVITY TROPONIN-I) AND A 510K NUMBER OF K202525. THE COMPLAINT INVESTIGATION FOR FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULTS INCLUDED A REVIEW OF COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, TRENDING DATA, LABELING, AND DEVICE HISTORY RECORDS. 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 VALUES FOR THE LOT ARE WITHIN THE ESTABLISHED LIMITS AND COMPARABLE TO THE HISTORICAL REAGENT LOT PERFORMANCE. A REVIEW OF TRACKING AND TRENDING FOR THE PRODUCT AND THE LIKELY CAUSE LOT DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. DEVICE HISTORY RECORD REVIEW DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES OR DEVIATIONS. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE. BASED ON THE INFORMATION PROVIDED AND ABBOTT DIAGNOSTICS¿ COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY FOR THE ALINITY I STAT HIGH SENSITIVE TROPONIN-I, LOT NUMBER 75633UD00, WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULT FOR A FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (<6 NG/L IS NEGATIVE, >16 NG/L IS POSITIVE): SAMPLE ID (B)(6) INITIAL RESULT, ON (B)(6) 2025, WAS 22.2, REPEAT RESULTS WERE <5.1, <5.1 NG/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581316 ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 75633UD00

    Patients

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