BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    MDR report key: 25028208 · Received April 29, 2026

    Report

    Report Number
    3005094123-2026-00199
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    April 20, 2026
    Report Date
    April 29, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740164133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P13, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 04Z21, ALINITY I STAT HIGH SENSITIVITY TROPONIN-I, WITH 510K/PMA/BLA NUMBER K202525. 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 REPORTED A FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULT GENERATED BY THE ALINITY I PROCESSING MODULE FOR A 29-YEAR-OLD MALE PATIENT UNDERGOING A PHYSICAL EXAMINATION. THE SAMPLE WAS TESTED ON THE ROCHE PLATFORM, WHICH PRODUCED A NORMAL RESULT. THE FOLLOWING DATA WAS PROVIDED: (B)(4). ALINITY I STAT HIGH SENSITIVE TROPONIN-I INITIAL RESULT = 2.008 NG/ML, REPEAT RESULT = 2.047 NG/ML (REFERENCE RANGE: 0.0342 NG/ML). ROCHE (TROPONIN T) RESULT = 0.012 (REFERENCE RANGE: 0.014). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239676 ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 83192UD01 00380740164133

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Male ALNTY I PROCESSING MODU, 03R65-01, AI24754.