BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT FREE T4 REAGENT KIT

    MDR report key: 19093266 · Received April 11, 2024

    Report

    Report Number
    3005094123-2024-00181
    Event Type
    Malfunction
    Date Received
    April 11, 2024
    Date of Event
    April 4, 2024
    Report Date
    April 23, 2024
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    CEC
    UDI-DI
    00380740119799
    PMA / PMN Number
    K173122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ARCHITECT FREE T4 REAGENT, LIST 07K65-29, ABBOTT IRELAND DIAGNOSTICS DIVISION, (B)(6), IRELAND TO THE ARCHITECT I1000 PROCESSING MODULE, LIST 01L86-01, ABBOTT LABORATORIES, (B)(6), TEXAS, USA. MDR NUMBER 3016438761-2024-00227-00 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT FREE T4 RESULTS FOR ONE PATIENT. THE RESULT WAS LOWER WHEN THE SAMPLES WERE REPEATED. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT SID (B)(6) PROCESSED (B)(6) 2024 = >5 NG/DL REPEAT RESULTS = 1.42 AND 1.03 NG/ML REFERENCE RANGE = 0.70 -1.48 NG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT FREE T4 RESULTS FOR ONE PATIENT. THE RESULT WAS LOWER WHEN THE SAMPLES WERE REPEATED. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT SID (B)(6) PROCESSED (B)(6)2024 = >5 NG/DL REPEAT RESULTS = 1.42 AND 1.03. NG/ML REFERENCE RANGE = 0.70 -1.48 NG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672222 ARCHITECT FREE T4 REAGENT KIT RADIOIMMUNOASSAY, FREE THYROXINE CEC ABBOTT IRELAND DIAGNOSTICS DIVISION 56026UD00 00380740119799

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I1000SR MOD, 01L86-01, (B)(6)| ARC I1000SR MOD, 01L86-01,(B)(6)