BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I FREE T4 REAGENT KIT

    MDR report key: 24754069 · Received April 1, 2026

    Report

    Report Number
    3005094123-2026-00152
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    March 24, 2026
    Report Date
    April 1, 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. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P70-77 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07P70, WITH 510K/PMA/BLA NUMBER K173122.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I FREE T4 RESULT FOR ONE 56 YEAR OLD FEMALE PATIENT. THE SAMPLE WAS REPEATED WITH A LOWER RESULT. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6), INITIAL RESULT = 20.81 PMOL/L REPEAT RESULT = 13.53 PMOL/L REFERENCE RANGE IS 9.01-19.05 PMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466631 ALINITY I FREE T4 REAGENT KIT RADIOIMMUNOASSAY, FREE THYROXINE CEC ABBOTT IRELAND DIAGNOSTICS DIVISION 82597UD01 00380740173715

    Patients

    Seq Age Sex Outcome Treatment
    1