BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    MDR report key: 23617176 · Received November 21, 2025

    Report

    Report Number
    3005094123-2025-00592
    Event Type
    Malfunction
    Date Received
    November 21, 2025
    Date of Event
    November 6, 2025
    Report Date
    November 21, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740186012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. THE TICKET SEARCH BY LOT INDICATES THAT THE REAGENT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. A REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I STAT HIGH SENSITIVE TROPONIN-I ASSAY DID NOT IDENTIFY ANY RELATED TRENDS. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCE OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT. THE OVERALL PERFORMANCE OF ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE PATIENT MEDIAN VALUES FOR LOTS 79018UD00 AND 79022UD00 (WHICH CONTAIN THE SAME BULK MATERIAL AS THE COMPLAINT LOT) ARE WITHIN THE ESTABLISHED LIMITS AND COMPARABLE TO THE HISTORICAL REAGENT LOT PERFORMANCE. LABELING REVIEW CONCLUDES THAT THE ISSUE IS ADEQUATELY ADDRESSED. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I STAT HIGH SENSITIVE TROPONIN-I, LOT 79021UD00 WAS IDENTIFIED. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P13 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4Z21, WITH 510K/PMA/BLA NUMBER K202525.

    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 FEMALE PATIENT. A SECOND SAMPLE FROM THE SAME PATIENT PRODUCED A RESULT WITHIN THE NORMAL RANGE. ADDITIONALLY, RETESTING OF THE INITIAL SAMPLE YIELDED A NORMAL RESULT. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S CUT-OFF FOR FEMALE: 15.6 NG/L SID (B)(6): ON (B)(6) 2025 FIRST SAMPLE: INITIAL RESULT = 154 NG/L, REPEAT RESULT = 1.4 NG/L SECOND SAMPLE: <1.3 NG/L . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2463309 ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 79021UD00 00380740186012

    Patients

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