BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    MDR report key: 24887594 · Received April 15, 2026

    Report

    Report Number
    3005094123-2026-00176
    Event Type
    Malfunction
    Date Received
    April 15, 2026
    Date of Event
    March 13, 2026
    Report Date
    April 15, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740160630
    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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P13 (ALINITY I STAT HIGHLY SENSITIVE TROPONIN-I) THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4Z21 (ALINITY I STAT HIGH SENSITIVITY TROPONIN-I) WITH 510K/PMA/BLA NUMBER K202525. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVITY TROPONIN-I RESULTS FOR A MALE PATIENT WHICH IS QUESTIONED BY THE DOCTOR. THE FOLLOWING DATA WAS PROVIDED (<26.2 = NORMAL): (B)(6) 2026 ALINITY RESULT = 86.4 UG/L TROPONIN T RESULT = POSITIVE. HISTORICAL RESULTS: (B)(6) 2025 TROPONIN I = 55.4 CK = 136 (B)(6) 2024 TROPONIN I = 42.2 CK = 121 CKMB = 12 (B)(6) 2023 TROPONIN I = 106.1 CK = 130 CKMB = 8 MYOGLOBIN = 17.5 LDH = 139 (B)(6) 2023 TROPONIN I = 161.2 CK = 176 CKMB = 13 MYOGLOBIN = <7.51 (B)(6) 2022 TROPONIN I = 116.4 CK = 119 CKMB = 10 MYOGLOBIN = 32.7 LDH = 132 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946944 ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 84075UD00 00380740160630

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male ALNTY I PROCESSING MODU, 03R65-01, (B)(6).