BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I FREE T4 REAGENT KIT

    MDR report key: 19903506 · Received August 4, 2024

    Report

    Report Number
    3005094123-2024-00408
    Event Type
    Malfunction
    Date Received
    August 4, 2024
    Date of Event
    July 24, 2024
    Report Date
    November 5, 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
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND IN HOUSE TESTING OF A RETAINED REAGENT KIT LOT 63095UD00. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. A SEARCH FOR SIMILAR COMPLAINTS DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 63095UD00. IN-HOUSE PERFORMANCE TESTING WAS COMPLETED WHICH CONCLUDED THE COMPLAINT LOT IS PERFORMING AS EXPECTED. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY ISSUES WITH THE COMPLAINT LOT. LABELING WAS REVIEWED AND WAS FOUND TO ADDRESS THE CUSTOMER REPORTED ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I FREE T4 REAGENT LOT 63095UD00 IDENTIFIED.

    Additional Manufacturer Narrative · 0

    A1 PATIENT IDENTIFIER: COMPLETE SAMPLE ID IS (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I FREE T4 GENERATED FROM AN ALINITY I PROCESSING MODULE AND PROVIDE THE FOLLOWING DATA: ON (B)(6) 2024 SAMPLE ID (B)(6) FIRST RESULT WAS >64.3 PMOL/L, WHICH WAS NOT CONSISTENT WITH TSH AND FREE T3 RESULTS. THE SAMPLE WAS REPEATED AND RESULT WAS 10.638 PMOL/L. WHEN REPEATED ON ANOTHER ALINITY INSTRUMENT, THE RESULT WAS 10.12 PMOL/L NOTE, THE CUSTOMER USED ANOTHER SAMPLE (SAMPLE ID (B)(6), WHICH WAS NOT THE SAMPLE THAT GENERATED DISCREPANT RESULTS AND PERFORMED A REPRODUCIBILITY/PRECISION STUDY. THE CUSTOMER OBTAINED THE FOLLOWING DATA: RUN 1 15.165 PMOL/L, RUN 2 14.918 PMOL/L, RUN 3 15.159 PMOL/L, RUN 4 15.872 PMOL/L, RUN 5 15.617 PMOL/L. PER THE CUSTOMER THE DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE PATIENT¿S MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I FREE T4 GENERATED FROM AN ALINITY I PROCESSING MODULE AND PROVIDE THE FOLLOWING DATA: ON (B)(6) 2024 SAMPLE ID (B)(6) FIRST RESULT WAS >64.3 PMOL/L, WHICH WAS NOT CONSISTENT WITH TSH AND FREE T3 RESULTS. THE SAMPLE WAS REPEATED AND RESULT WAS 10.638 PMOL/L. WHEN REPEATED ON ANOTHER ALINITY INSTRUMENT, THE RESULT WAS 10.12 PMOL/L. NOTE, THE CUSTOMER USED ANOTHER SAMPLE (SAMPLE ID (B)(6)), WHICH WAS NOT THE SAMPLE THAT GENERATED DISCREPANT RESULTS AND PERFORMED A REPRODUCIBILITY/PRECISION STUDY. THE CUSTOMER OBTAINED THE FOLLOWING DATA: RUN 1 15.165 PMOL/L, RUN 2 14.918 PMOL/L, RUN 3 15.159 PMOL/L, RUN 4 15.872 PMOL/L, RUN 5 15.617 PMOL/L. PER THE CUSTOMER THE DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE PATIENT¿S MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015125 ALINITY I FREE T4 REAGENT KIT RADIOIMMUNOASSAY, FREE THYROXINE CEC ABBOTT IRELAND DIAGNOSTICS DIVISION 63095UD00 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).