BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    MDR report key: 25071083 · Received May 4, 2026

    Report

    Report Number
    3005094123-2026-00208
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    March 24, 2026
    Report Date
    May 4, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740160647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. 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 A FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULT FOR ONE MALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2026: FIRST SAMPLE WITH SID (B)(6) WAS TAKEN FROM THE PATIENT AND RAN ON INSTRUMENT AT 00:49 WITH RESULT 21.412 NG/L (REFERENCE RANGE FOR MALE PATIENT IS <34 NG/L). NEW SAMPLE WITH SID (B)(6) WAS TAKEN FROM THE PATIENT IN THE MORNING AND STORED ON THE TRACK STORAGE MODULE. IT WAS RUN ON THE INSTRUMENT IN THE AFTERNOON AT 14:51 WITH RESULT 437.014 NG/L. SID (B)(6) WAS RERUN ON INSTRUMENT (B)(6) WITH RESULTS 270.055 NG/L AND 351.901 NG/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181831 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