BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    MDR report key: 24444155 · Received February 25, 2026

    Report

    Report Number
    3005094123-2026-00093
    Event Type
    Malfunction
    Date Received
    February 25, 2026
    Date of Event
    February 14, 2026
    Report Date
    April 22, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740160647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P13-34, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 04Z21, ALINITY I STAT HIGH SENSITIVITY TROPONIN-I, WITH 510K/PMA/BLA NUMBER K202525.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I GENERATED FROM ALINITY I PROCESSING MODULE (SN: (B)(6) AND PROVIDED THE FOLLOWING DATA: CUSTOMER REFERENCE RANGE: 0 - 4.9 NG/L PATIENT 1: 25 YEAR OLD FEMALE SAMPLE ID (B)(6). ON (B)(6) 2026, INITIAL RESULT WAS 7.0 NG/L. ON (B)(6) 2026, THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER (SN: (B)(6) AND THE RESULT WAS 1.13 NG/L. PATIENT 2: 56 YEAR OLD MALE SAMPLE ID (B)(6). ON (B)(6) 2026, INITIAL RESULT WAS 13.4 NG/L. WHEN REPEATED ON ANOTHER ANALYZER (SN: (B)(6) AND THE RESULT WAS 1.7 NG/L. PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510403 ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 81566UD00 00380740160647

    Patients

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