BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    MDR report key: 25183438 · Received May 15, 2026

    Report

    Report Number
    3005094123-2026-00226
    Event Type
    Malfunction
    Date Received
    May 15, 2026
    Date of Event
    April 23, 2026
    Report Date
    May 15, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740160630
    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 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 OBSERVED FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULTS FOR A 78-YEAR-OLD MALE PATIENT. (CUSTOMER PROVIDED REFERENCE RANGE = <34.2 NG/L). SID (B)(6) INITIAL RESULT = 409.2 NG/L, REPEAT RESULT ON ANOTHER ALINITY (AI03167) = 545 NG/L, RESULT AT THE HOSPITAL ON UNKNOWN METHOD = NEGATIVE (NO SPECIFIC DATA RESULT PROVIDED). THE SAMPLE WAS TESTED WITH VIDAS = POSITIVE (NO SPECIFIC RESULT WAS PROVIDED). ADDITIONAL LAB RESULT PROVIDED: CREATININE PHOSPHOKINASE = 76 (NORMAL RANGE: 30-200) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422886 ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 84075UD00 00380740160630

    Patients

    Seq Age Sex Outcome Treatment
    1