BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I FREE T4 REAGENT KIT

    MDR report key: 20062872 · Received August 26, 2024

    Report

    Report Number
    3005094123-2024-00443
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    August 6, 2024
    Report Date
    October 4, 2024
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    CEC
    UDI-DI
    00380740121815
    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

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A1 PATIENT IDENTIFIER COMPLETE SID : (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, DEVICE HISTORY RECORD REVIEW, AND LABELING REVIEW. ADDITIONALLY, IN-HOUSE TESTING WAS PERFORMED. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A SEARCH FOR SIMILAR COMPLAINTS DID IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY, HOWEVER, NO RELATED TRENDS WERE IDENTIFIED REGARDING COMMONALITIES FOR LOT NUMBER 59141UD00 AND ISSUE FOR THE PRODUCT. ADDITIONALLY, IN-HOUSE PERFORMANCE TESTING WAS COMPLETED WHICH INDICATES THE PRODUCT IS PERFORMING AS EXPECTED. THE DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH LOT NUMBER 59141UD00 AND THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I FREE T4 FOR LOT 59141UD00 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I FREE T4 (FT4) RESULT ON A PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2024 SID (B)(6) FT4 = >5.00 NG/DL; FT3 = 2.62 PG/ML; TSH = 0.5780 UIU/ML. REPEATED ON (B)(6) 2024: FT4 = 1.03 NG/DL; FT3 = 2.25 PG/ML; TSH = 0.5799 UIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I FREE T4 (FT4) RESULT ON A PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2024 SID (B)(6) FT4 = >5.00 NG/DL; FT3 = 2.62 PG/ML; TSH = 0.5780 UIU/ML. REPEATED ON (B)(6) 2024: FT4 = 1.03 NG/DL; FT3 = 2.25 PG/ML; TSH = 0.5799 UIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1194244 ALINITY I FREE T4 REAGENT KIT RADIOIMMUNOASSAY, FREE THYROXINE CEC ABBOTT IRELAND DIAGNOSTICS DIVISION 59141UD00 00380740121815

    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)