BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    MDR report key: 25050549 · Received April 30, 2026

    Report

    Report Number
    3005094123-2026-00203
    Event Type
    Malfunction
    Date Received
    April 30, 2026
    Date of Event
    April 10, 2026
    Report Date
    April 30, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740160647
    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 A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P13 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4Z21, AND 510K/PMA/BLA OF K202525. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I STAT HIGHLY SENSITIVE TROPONIN-I FOR ONE FEMALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE, MALE, < 34.2 PG/ML): ON (B)(6) 2026, SID (B)(6), INITIAL TROPONIN RESULT= 3.7 PG/ML (NEGATIVE); REPEAT RESULT= 39.5075 PG/ML (POSITIVE); REPEAT RESULT (ANALYZER (B)(6) = < 3.7000 PG/ML AND < 3.7000 PG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225273 ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 82211UD00 00380740160647

    Patients

    Seq Age Sex Outcome Treatment
    1