BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    MDR report key: 24462037 · Received February 26, 2026

    Report

    Report Number
    3005094123-2026-00098
    Event Type
    Malfunction
    Date Received
    February 26, 2026
    Date of Event
    February 16, 2026
    Report Date
    May 19, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740160647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 PROVIDED, NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P13-34 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4Z21, 510K K202525.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE POSITIVE ALINITY I TROPONIN RESULT GENERATED ON AN ALINITY I PROCESSING MODULE FOR A 63-YEAR-OLD FEMALE PATIENT. SID (B)(6) INITIAL RESULT = 117.5 PG/ML, A NEW SAMPLE GENERATED A RESULT OF <4 PG/ML; THE INITIAL SAMPLE WAS REPEATED GENERATING A RESULT OF <4 PG/ML. THE CUSTOMER CUTOFF IS <16 PG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505338 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 63 YR Female ALNTY I PROCESSING MODU, 03R65-01, (B)(6)