BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    MDR report key: 25112170 · Received May 7, 2026

    Report

    Report Number
    3005094123-2026-00215
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    April 30, 2026
    Report Date
    May 7, 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. ALL AVAILABLE PATIENT INFORMATION HAS BEEN INCLUDED. NO ADDITIONAL PATIENT DETAILS ARE AVAILABLE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P13-24 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4Z21, WITH 510K NUMBER K202525.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULT. ON (B)(6) 2026, SID (B)(6) (FEMALE, 55 YEARS OLD) GENERATED TROPONIN OF 25.78 NG/L POSITIVE, WHICH WAS QUESTIONED. A NEW SAMPLE WAS OBTAINED AN HOUR LATER TESTING TROPONIN OF 1.3 NG/L NEGATIVE. THE ORIGINAL SAMPLE, SID (B)(6), WAS REPEATED WITH <1 NG/L NEGATIVE RESULTS. THE CUSTOMER CUT OFF FOR A POSITIVE RESULT IS =/> 5.0 NG/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433637 ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 83194UD00 00380740160647

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female ALNTY I PROCESSING MODU, 03R65-01, (B)(6)