BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    MDR report key: 24730594 · Received March 30, 2026

    Report

    Report Number
    3005094123-2026-00148
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 7, 2026
    Report Date
    May 12, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740160630
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GG
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A1 PATIENT IDENTIFIER COMPLETE INFORMATION: (B)(6). 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. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULT GENERATED ON THE ALINITY I PROCESSING MODULE FOR A 49-YEAR-OLD MALE PATIENT BROUGHT INTO THE EMERGENCY DEPARTMENT PRESENTING WITH CHEST PAIN. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6). FIRST RESULT = 227.1 NG/L. BASED ON THIS ELEVATED RESULT, THE PATIENT UNDERWENT A CORONARY ANGIOGRAM. SIX HOURS LATER, A REPEAT TEST WAS PERFORMED, AND THE SAMPLE GENERATED A RESULT OF 1.1 NG/L. THE FIRST RESULT WAS QUESTIONED DUE TO THE SIGNIFICANT DIFFERENCE. A THIRD SAMPLE WAS TESTED FOR TROPONIN-I AND GENERATED A RESULT OF 2.1 NG/L. THE ORIGINAL SAMPLE WAS RETESTED AND GENERATED A RESULT OF 0.2 NG/L. THERE WAS NO FURTHER IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264823 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 49 YR Male ALNTY I PROCESSING MODU, 03R65-01, (B)(6)