BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    MDR report key: 25186774 · Received May 15, 2026

    Report

    Report Number
    3005094123-2026-00227
    Event Type
    Malfunction
    Date Received
    May 15, 2026
    Date of Event
    May 5, 2026
    Report Date
    May 15, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740160630
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION E1 - PHONE NUMBER: COMPLETE PHONE IS (B)(6). SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. 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 FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 0-34.2 PG/ML): (B)(6) 2026 SAMPLE ID (B)(6) INITIAL RESULT = 285 PG/ML, REPEAT RESULT WITH 1:10 DILUTION = 318 PG/ML, RESULT WITH 1:20 DILUTION = 412.5 PG/ML; AT ANOTHER FACILITY, TROPONIN T WAS WITHIN NORMAL RANGE; NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319042 ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 84471UD00 00380740160630

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Male ALNTY I PROCESSING MODU, 03R65-01, AI23190