BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I FREE T4 REAGENT KIT

    MDR report key: 19166635 · Received April 23, 2024

    Report

    Report Number
    3005094123-2024-00194
    Event Type
    Malfunction
    Date Received
    April 23, 2024
    Date of Event
    December 1, 2023
    Report Date
    May 22, 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
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS ISSUE WAS PREVIOUSLY REPORTED UNDER MDR NUMBER 3016438761-2024-00109-00 UNDER A DIFFERENT SUSPECT DEVICE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    A REVIEW OF CUSTOMER DATA ALIGNED WITH CUSTOMER¿S ISSUE AND NO ADDITIONAL ISSUES WERE IDENTIFIED. AN INCREASE IN COMPLAINTS HAS BEEN OBSERVED FOR LOT 53312UD04, HOWEVER, IN-HOUSE PERFORMANCE TESTING WAS COMPLETED WHICH INDICATES THE PRODUCT IS PERFORMING AS EXPECTED. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE LIST NUMBER AND COMPLAINT ISSUE. IN-HOUSE PERFORMANCE TESTING WAS COMPLETED WHICH INDICATES THE PRODUCT IS PERFORMING AS EXPECTED. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I FREE T4 ASSAY WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 RESULTS FOR THREE PATIENTS. THE FOLLOWING DATA WAS PROVIDED (NORMAL REFERENCE RANGE 0.6-1.8 NG/DL): (B)(6) 2024 SID (B)(6) INITIAL RESULT 2.6 NG/DL, REPEATED 1.2 / 0.91 / 1.86 / 0.96 / 1.95 NG/DL (B)(6) 2024 SID UNK INITIAL RESULT 2.09 NG/DL, REPEATED 1.02 NG/DL. (B)(6) 2024 SID (B)(6) INITIAL RESULT >5 NG/DL, REPEATED 1.0 NG/DL. (B)(6) 2024 SID (B)(6) INITIAL RESULT 2.45 NG/DL, REPEAT ON ANOTHER ANALYZER RESULTED 1.62 NG/DL, (B)(6) 2024 SID (B)(6) INITIAL RESULT 2.23 NG/DL, REPEAT 1.37 NG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947063 ALINITY I FREE T4 REAGENT KIT RADIOIMMUNOASSAY, FREE THYROXINE CEC ABBOTT IRELAND DIAGNOSTICS DIVISION 53312UD04 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)