BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    MDR report key: 24546976 · Received March 9, 2026

    Report

    Report Number
    3005094123-2026-00110
    Event Type
    Malfunction
    Date Received
    March 9, 2026
    Date of Event
    February 27, 2026
    Report Date
    March 9, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740164157
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P13 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4Z21, WITH 510K NUMBER K202525.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY DECREASED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULTS GENERATED BY THE ALINITY I PROCESSING MODULE FOR THREE PATIENTS. THE SAMPLES WERE REPEATED, AND HIGHER RESULTS WERE OBTAINED. THE FOLLOWING DATA WERE PROVIDED: REFERENCE RANGES: MALE IS 0.000 TO 0.034 NG/ML; FEMALE IS 0.000 TO 0.016 NG/ML. SID (B)(6), (54-YEAR-OLD FEMALE): INITIAL RESULT = 0.012 NG/ML, REPEAT RESULT = 0.024 NG/ML. SID (B)(6), (75-YEAR-OLD MALE): INITIAL RESULT = 0.025 NG/ML, REPEAT RESULT = 0.055 NG/ML. SID (B)(6), (85-YEAR-OLD MALE): INITIAL RESULT = 0.032 NG/ML, REPEAT RESULT = 0.054 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605291 ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 83194UD01 00380740164157

    Patients

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