BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    MDR report key: 25001667 · Received April 27, 2026

    Report

    Report Number
    3005094123-2026-00194
    Event Type
    Malfunction
    Date Received
    April 27, 2026
    Date of Event
    April 12, 2026
    Report Date
    May 14, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740160630
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P13-24 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4Z21, WITH 510K NUMBER K202525. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I STAT HIGHLY SENSITIVE TROPONIN-I RESULTS FOR ONE FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SID 156339861305 ALINITY I STAT HIGH-SENSITIVE TROPONIN-I RESULTS: (B)(6) 2026 23:27H 454.3 NG/L, (B)(6) 2026 19:45H 482.9 NG/L, (B)(6) 2026 19:12H 43.6 NG/L, (NORMAL RANGE <15.6 NG/L). ROCHE TROPONIN T (SERUM) 5.21 NG/L, LI-HEPARIN 5.59 NG/L (NORMAL RANGE <40 PG/ML). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254209 ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 84471UD00 00380740160630

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female ALNTY I PROCESSING MODU, 03R65-01, AI20103.