BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT FREE T4 REAGENT KIT

    MDR report key: 19679626 · Received July 5, 2024

    Report

    Report Number
    3005094123-2024-00366
    Event Type
    Malfunction
    Date Received
    July 5, 2024
    Date of Event
    June 15, 2024
    Report Date
    September 16, 2024
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    CEC
    UDI-DI
    00380740173678
    PMA / PMN Number
    K173122
    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.

    Additional Manufacturer Narrative · 0

    SECTION D4: PRIMARY UDI NUMBER: THIS SECTION WAS CORRECTED FROM (B)(4) TO (B)(4). THE COMPLAINT INVESTIGATION FOR FALSELY ELEVATED ARCHITECT FREE T4 RESULT INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, TICKET TRENDING REVIEW, DEVICE HISTORY RECORD REVIEW, AND LABELING REVIEW. IN ADDITION, IN-HOUSE TESTING OF RETAINED REAGENT KIT WAS ALSO COMPLETED. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A REVIEW OF THE COMPLAINT TRENDING REPORT DID IDENTIFY AN INCREASE IN COMPLAINTS FOR LOT 61272UD02, HOWEVER, IN-HOUSE PERFORMANCE TESTING WAS COMPLETED WHICH INDICATES THE PRODUCT IS PERFORMING AS EXPECTED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCE'S OR DEVIATIONS WITH LOT NUMBER 61272UD02 AND THE COMPLAINT ISSUE. A REVIEW OF LABELING WAS PERFORMED AND FOUND TO SUFFICIENTLY ADDRESS THE CUSTOMER'S ISSUE. BASED ON THIS INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ARCHITECT FREE T4 REAGENT, LOT NUMBER 61272UD02.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT FREE T4 RESULT GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR ONE PATIENT. THE SAMPLE WAS REPEATED AND A NORMAL RESULT WAS OBTAINED. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S REFERENCE RANGE: 9.01 TO 19.05 PMOL/L INITIAL ARCHITECT FREE T4 RESULT = >64 PMOL/L, REPEAT RESULT = 18.14 PMOL/L THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT FREE T4 RESULT GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR ONE PATIENT. THE SAMPLE WAS REPEATED AND A NORMAL RESULT WAS OBTAINED. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S REFERENCE RANGE: 9.01 TO 19.05 PMOL/L. INITIAL ARCHITECT FREE T4 RESULT = >64 PMOL/L, REPEAT RESULT = 18.14 PMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133887 ARCHITECT FREE T4 REAGENT KIT RADIOIMMUNOASSAY, FREE THYROXINE CEC ABBOTT IRELAND DIAGNOSTICS DIVISION 61272UD02 00380740173678

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I2000SR INST, 03M74-02, ISR62378.| ARC I2000SR INST, 03M74-02, ISR62378.