BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT FREE T4 REAGENT KIT

    MDR report key: 19795140 · Received July 22, 2024

    Report

    Report Number
    3005094123-2024-00384
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    July 5, 2024
    Report Date
    September 23, 2024
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    CEC
    UDI-DI
    00380740119805
    PMA / PMN Number
    K173122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. AN INCREASE IN COMPLAINTS HAS BEEN OBSERVED FOR LOT 57269UD00, HOWEVER, IN-HOUSE PERFORMANCE TESTING WAS COMPLETED WHICH INDICATES THE PRODUCT IS PERFORMING AS EXPECTED. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES, OR DEVIATIONS ASSOCIATED WITH LOT 57269UD00 AND THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ARCHITECT FREE T4 FOR REAGENT FOR LOT 57269UD00 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    COMPLETE ENTRY FOR SECTION A1 - PATIENT IDENTIFIER: (B)(6). 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 AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT FREE T4 FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: SID: (B)(6), INITIAL TEST > 5.0 NG/DL; REPEAT RESULT= 2.41 NG/DL. ADDITIONAL INFORMATION WAS PROVIDED: TSH= 1.066 UIU/ML; TSH 1:5 DILUTION= 1.371 UIU/ML; FT3= 1.81 PG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT FREE T4 FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: SID: (B)(6) , INITIAL TEST > 5.0 NG/DL; REPEAT RESULT= 2.41 NG/DL. ADDITIONAL INFORMATION WAS PROVIDED: TSH= 1.066 UIU/ML; TSH 1:5 DILUTION= 1.371 UIU/ML; FT3= 1.81 PG/ML . THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2250790 ARCHITECT FREE T4 REAGENT KIT RADIOIMMUNOASSAY, FREE THYROXINE CEC ABBOTT IRELAND DIAGNOSTICS DIVISION 57269UD00 00380740119805

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I2K PROC MOD, 03M74-01, (B)(6). | ARC I2K PROC MOD, 03M74-01, (B)(6).