BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    MDR report key: 24543828 · Received March 9, 2026

    Report

    Report Number
    3005094123-2026-00109
    Event Type
    Malfunction
    Date Received
    March 9, 2026
    Date of Event
    March 1, 2026
    Report Date
    May 18, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740164133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 A ONE PATIENT. (REFERENCE RANGE IS 0-0.026 NG/ML) INITIAL RESULT = 1.7 NG/ML, PATIENT¿S PAST RESULT = 0.5 NG/ML TROPONIN T RESULT AT ANOTHER HOSPITAL WITH ROCHE PLATFORM = NEGATIVE (NO SPECIFIC DATA PROVIDED) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301739 ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 82209UD01 00380740164133

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown