BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    MDR report key: 25001026 · Received April 27, 2026

    Report

    Report Number
    3005094123-2026-00192
    Event Type
    Malfunction
    Date Received
    April 27, 2026
    Date of Event
    April 15, 2026
    Report Date
    April 27, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740160630
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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, WITH 510K/PMA/BLA NUMBER K202525. SECTION E: E1 - ADDRESS 1: COMPLETE ADDRESS INFORMATION: DEPARTMENT OF CLINICAL BIOCHEMISTRY AND DIAGNOSTIC ENDOCRINOLOGY AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    A CONFERENCE ABSTRACT BY CULLEN, M.R., AND LEE, G.R., ¿EVALUATION OF FREE THYROXINE AND HIGH SENSITIVITY CARDIAC TROPONIN DUPLICATE TESTING,¿ CLINICAL CHEMISTRY AND LABORATORY MEDICINE, 2026; 64(4): EA78. DOI: 10.1515/CCLM-2026-0148, DESCRIBES THE USE OF ROUTINE DUPLICATE TESTING AS A RISK MANAGEMENT STRATEGY TO DETECT ANALYTICAL ERRORS IN ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN I RESULTS GENERATED BY THE ALINITY I PROCESSING MODULES. DUPLICATE TESTING WAS PERFORMED FOR ALL ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN I RESULTS >7 NG/L. ANALYTICAL ERROR WAS DETECTED IN 112 (B)(4) OF 13,772 DUPLICATE MEASUREMENTS, WITH CRITICAL ERRORS (THOSE CROSSING SEX SPECIFIC (B)(4) PERCENTILE DECISION LIMITS) OCCURRING IN ONLY 5 (0.04%) OF CASES. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532776 ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 00380740160630

    Patients

    Seq Age Sex Outcome Treatment
    1