BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    MDR report key: 25305176 · Received May 27, 2026

    Report

    Report Number
    3005094123-2026-00253
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Date of Event
    May 15, 2026
    Report Date
    May 27, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740160647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 SENSITIVITY TROPONIN-I RESULTS FOR ONE 50-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) COLLECTED AT 12:35 (B)(6) 2026 INITIAL RESULT = 83.3 NG/L REPEAT RESULTS = 6.6 AND 6.1 NG/L SID (B)(6) SAME PATIENT DIFFERENT SAMPLE RECEIVED AT 14:26 ON (B)(6) 2026 = 4.9 NG/L REPEAT RESULTS = 4.4 AND 4.6 NG/L. REFERENCE RANGE FOR FEMALES = 0-17 NG/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616980 ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 83194UD00 00380740160647

    Patients

    Seq Age Sex Outcome Treatment
    1