BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    MDR report key: 24756421 · Received April 1, 2026

    Report

    Report Number
    3005094123-2026-00154
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    March 26, 2026
    Report Date
    April 1, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740164157
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P13 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4Z21 (ALINITY I STAT HIGH SENSITIVITY TROPONIN-I), WITH 510K/PMA/BLA NUMBER K202525.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVITY TROPONIN-I RESULT FOR A 1 DAY OLD NEWBORN FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER PROVIDED REFERENCE RANGE IS <15.4 PG/ML): SID (B)(6): INITIAL RESULT = 253 PG/ML, REPEAT WITH PEG = 11.2 PG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816353 ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 81566UD01 00380740164157

    Patients

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