BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I FREE T4 REAGENT KIT

    MDR report key: 20543340 · Received October 28, 2024

    Report

    Report Number
    3005094123-2024-00552
    Event Type
    Malfunction
    Date Received
    October 28, 2024
    Date of Event
    September 26, 2024
    Report Date
    November 20, 2024
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    CEC
    UDI-DI
    00380740121822
    PMA / PMN Number
    K173122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE TO SECTION A1 - PATIENT IDENTIFIER FROM MULTIPLE TO (B)(6) UPDATE TO SECTION B3 - DATE OF EVENT FROM 9/24/2024 TO 9/26/2024 UPDATE TO SECTION B5 - DESCRIBE EVENT OR PROBLEM TO REMOVE PATIENT SID CB312072 AS THE RESULTS HAVE BEEN REPORTED IN REPORT 075075RE2352483. UPDATE TO SECTION H6 - ADVERSE EVENT PROBLEM FROM A090807 TO A090809 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 65500UD00, 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 65500UD00 AND THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I FREE T4 FOR LOT 65500UD00 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 FALSELY ELEVATED ALINITY I FREE T4 FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 8.0 - 19.1 PMOL/L): (B)(6) 2024, SID (B)(6), INITIAL FREE T4 >64.4PMOL/L, THE SAMPLE INITIALLY WAS REPEATED A TOTAL OF FIVE TIMES WITH ERROR CODE EC3424 SAMPLE ASPIRATION ERROR; REPEAT RESULT= 16.1 PMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 FOR TWO PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 8.0 - 19.1 PMOL/L): ON (B)(6) 2024, SID (B)(6), INITIAL FREE T4 (AI20079) >64.4 PMOL/L; REPEAT RESULT= 15.2 PMOL/L. ON (B)(6) 2024, SID (B)(6), INITIAL FREE T4 >64.4PMOL/L, THE SAMPLE INITIALLY WAS REPEATED A TOTAL OF FIVE TIMES WITH ERROR CODE EC3424 SAMPLE ASPIRATION ERROR; REPEAT RESULT= 16.1 PMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1166732 ALINITY I FREE T4 REAGENT KIT RADIOIMMUNOASSAY, FREE THYROXINE CEC ABBOTT IRELAND DIAGNOSTICS DIVISION 65500UD00 00380740121822

    Patients

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