BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    MDR report key: 24814361 · Received April 8, 2026

    Report

    Report Number
    3005094123-2026-00167
    Event Type
    Malfunction
    Date Received
    April 8, 2026
    Date of Event
    March 18, 2026
    Report Date
    April 8, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740186012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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, 510K/PMA/BLA K202525. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. 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 79-YEAR-OLD MALE PATIENT. THE PHYSICIAN QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED, AND A NORMAL RESULT WAS OBTAINED. THE FOLLOWING DATA WAS PROVIDED: REFERENCE RANGE: 0 TO 34 NG/L SID (B)(6). INITIAL RESULT = 75.6 NG/L, REPEAT RESULT = 7.0 NG/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878101 ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 81021UD00 00380740186012

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male ALNTY I PROCESSING MODU, 03R65-01, (B)(6).