BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    MDR report key: 24799349 · Received April 7, 2026

    Report

    Report Number
    3005094123-2026-00166
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    March 13, 2026
    Report Date
    May 11, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740160630
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P13 (ALINITY I STAT HIGH SENSITIVE TROPONIN-I) THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4Z21 (ALINITY I STAT HIGH SENSITIVITY TROPONIN-I) WITH 510K/PMA/BLA NUMBER K202525. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULTS FOR ONE PATIENT. (REFERENCE RANGE: <26 NG/L) INITIAL RESULT = >3000 NG/L AND THE PATIENT WAS ADMITTED TO THE CLINIC AND THE HIGH TROPONIN RESULT NOT CONFIRMED (NO REPEAT RESULT WAS PROVIDED) FOR FOLLOW UP TESTING, NEW SAMPLE WAS DRAWN WITH ELEVATED TROPONIN RESULTS (NO SPECIFIC RESULTS WERE PROVIDED). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522222 ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 81564UD00 00380740160630

    Patients

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