BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I FREE T4 REAGENT KIT

    MDR report key: 24694871 · Received March 25, 2026

    Report

    Report Number
    3005094123-2026-00143
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    March 16, 2026
    Report Date
    March 25, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    CEC
    UDI-DI
    00380740173715
    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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT PROVIDED. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P70-77 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P70-30, 510K K173122.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I FREE T4 RESULT GENERATED ON THE ALINITY I PROCESSING MODULE FOR ONE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE: 9.01-19.05 PMOL/L) : SID (B)(6), (43-YEAR-OLD, MALE): INITIAL RESULT = > 64.35 PMOL/L (RESULT INCONSISTENT WITH PATIENT¿S MEDICAL HISTORY) REPEAT RESULT = 13.52 PMOL/L . THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174746 ALINITY I FREE T4 REAGENT KIT RADIOIMMUNOASSAY, FREE THYROXINE CEC ABBOTT IRELAND DIAGNOSTICS DIVISION 79271UD01 00380740173715

    Patients

    Seq Age Sex Outcome Treatment
    1