BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    MDR report key: 25101109 · Received May 6, 2026

    Report

    Report Number
    3005094123-2026-00212
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    April 18, 2026
    Report Date
    May 6, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740160647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 04Z21, WITH 510K/PMA/BLA NUMBER K202525.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULT GENERATED ON THE ALINITY I PROCESSING MODULE (SN: (B)(6) FOR A MALE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE: <34.2 NG/L FOR MALE PATIENTS): (B)(6) 2026 INITIAL RESULT FOR SAMPLE ID (B)(6) = 608.1 NG/L. THIS RESULT WAS QUESTIONED. THE SAME SAMPLE WAS REPEATED ON ANOTHER ALINITY INSTRUMENT (SN: (B)(6), AND THE RESULT = 12.9 NG/L A SECOND SAMPLE WAS OBTAINED FROM THE SAME PATIENT. SAMPLE ID (B)(6) RESULT ON INSTRUMENT (B)(6) = 16.8 NG/L, REPEAT RESULT ON INSTRUMENT (B)(6) = 14.5 NG/L. A THIRD SAMPLE WAS OBTAINED FROM THE SAME PATIENT (SAMPLE ID (B)(6) AND THE RESULT ON INSTRUMENT (B)(6) = 20.1 NG/L, RESULT ON INSTRUMENT (B)(6) = 17.2 NG/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587246 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