BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    MDR report key: 24484452 · Received March 2, 2026

    Report

    Report Number
    3005094123-2026-00101
    Event Type
    Malfunction
    Date Received
    March 2, 2026
    Date of Event
    February 2, 2026
    Report Date
    May 21, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740160647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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 08P13-34 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, ALINITY I STAT HIGH SENSITIVITY TROPONIN-I, LIST NUMBER 04Z21, 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 OBSERVED FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULTS GENERATED BY THE ALINITY I PROCESSING MODULE FOR MULTIPLE PATIENTS. THE FOLLOWING DATA WERE PROVIDED: LAB REFERENCE RANGE: FEMALE IS <16 NG/L, MALE IS <34 NG/L. LOT#79329UD00: (B)(6) 2026, SID (B)(6), (72-YEAR-OLD, FEMALE): INITIAL RESULT = 242 NG/L (B)(6), REPEAT RESULT = <10 NG/L (B)(6). (B)(6) 2026, SID (B)(6), (52-YEAR-OLD, MALE): INITIAL RESULT = 59.36 NG/L (B)(6), REPEAT RESULT = <10 NG/L (B)(6). (B)(6) 2026, SID (B)(6), (70-YEAR-OLD, MALE): INITIAL RESULT = 65.46 NG/L (B)(6), REPEAT RESULT = 23.55 NG/L (B)(6). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68721 ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 79329UD00 00380740160647

    Patients

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