BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I FREE T4 REAGENT KIT

    MDR report key: 20170897 · Received September 9, 2024

    Report

    Report Number
    3005094123-2024-00466
    Event Type
    Malfunction
    Date Received
    September 9, 2024
    Date of Event
    April 15, 2024
    Report Date
    October 24, 2024
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    CEC
    UDI-DI
    00380740121822
    PMA / PMN Number
    K173122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. AN INCREASE IN COMPLAINTS HAS BEEN OBSERVED FOR LOTS 57607UD00 AND 56201UD00, HOWEVER, IN-HOUSE PERFORMANCE TESTING WAS COMPLETED WHICH INDICATES THE PRODUCT IS PERFORMING AS EXPECTED. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES, OR DEVIATIONS ASSOCIATED WITH LOT 57607UD00 OR LOT 56201UD00 AND THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I FREE T4 FOR REAGENT FOR LOT 57607UD00 OR LOT 56201UD00 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 RESULTS FOR MULTIPLE SAMPLES ACROSS TWO LOT NUMBERS AND TWO INSTRUMENTS. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2024 SID (B)(6) INITIAL RESULT WAS >5.00 NG/DL, REPEAT = 1.470 NG/DL (B)(6) 2024 SID (B)(6) INITIAL RESULT WAS >5.00 NG/DL, REPEAT = 1.310 NG/DL (B)(6) 2024 SID (B)(6) INITIAL RESULT = 2.20 NG/DL, REPEAT = 1.970 NG/DL (B)(6) 2024 SID (B)(6) INITIAL RESULT WAS >5.00 NG/DL, REPEAT = 2.660 NG/DL (B)(6) 2024 SID (B)(6) INITIAL RESULT WAS >5.00 NG/DL, REPEAT = 0.950 NG/DL (B)(6) 2024 SID (B)(6) INITIAL RESULT WAS >5.00 NG/DL, REPEAT = 1.120 NG/DL (B)(6) 2024 SID (B)(6) INITIAL RESULT WAS >5.00 NG/DL, REPEAT = 1.130 NG/DL (B)(6) 2024 SID (B)(6) INITIAL RESULT WAS >5.00 NG/DL, REPEAT = 1.030 NG/DL (B)(6) 2024 SID (B)(6) INITIAL RESULT WAS >5.00 NG/DL, REPEAT = 0.830 NG/DL (B)(6) 2024 SID (B)(6) INITIAL RESULT WAS >5.00 NG/DL, REPEAT = 1.100 NG/DL (B)(6) 2024 SID (B)(6) INITIAL RESULT WAS >5.00 NG/DL, REPEAT = 1.480 NG/DL (B)(6) 2024 SID (B)(6) INITIAL RESULT WAS >5.00 NG/DL, REPEAT = 0.790 NG/DL (B)(6) 2024 SID (B)(6) INITIAL RESULT WAS >5.00 NG/DL, REPEAT = 1.910 NG/DL (B)(6) 2024 SID (B)(6) INITIAL RESULT WAS >5.00 NG/DL, REPEAT = 1.300 NG/DL (B)(6) 2024 SID (B)(6) INITIAL RESULT WAS >5.00 NG/DL, REPEAT WAS >5.00 NG/DL (B)(6) 2024 SID (B)(6) INITIAL RESULT WAS >5.00 NG/DL, REPEAT = 0.960 NG/DL (B)(6) 2024 SID (B)(6) INITIAL RESULT 2.11 NG/DL, REPEAT = 0.710 NG/DL (B)(6) 2024 SID (B)(6) INITIAL RESULT WAS 3.68 NG/DL, REPEAT = 2.280 NG/DL (B)(6) 2024 SID (B)(6) INITIAL RESULT WAS 2.47 NG/DL, REPEAT = 1.11 NG/DL (B)(6) 2024 SID (B)(6) INITIAL RESULT WAS 1.88 NG/DL, REPEAT = 1.300 NG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 RESULTS FOR MULTIPLE SAMPLES ACROSS TWO LOT NUMBERS AND TWO INSTRUMENTS. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2024 SID (B)(6) INITIAL RESULT WAS >5.00 NG/DL, REPEAT = 1.470 NG/DL. (B)(6) 2024 SID (B)(6) INITIAL RESULT WAS >5.00 NG/DL, REPEAT = 1.310 NG/DL. (B)(6) 2024 SID (B)(6) INITIAL RESULT = 2.20 NG/DL, REPEAT = 1.970 NG/DL. (B)(6) 2024 SID (B)(6) INITIAL RESULT WAS >5.00 NG/DL, REPEAT = 2.660 NG/DL. (B)(6) 2024 SID (B)(6) INITIAL RESULT WAS >5.00 NG/DL, REPEAT = 0.950 NG/DL. (B)(6) 2024 SID (B)(6) INITIAL RESULT WAS >5.00 NG/DL, REPEAT = 1.120 NG/DL. (B)(6) 2024 SID (B)(6) INITIAL RESULT WAS >5.00 NG/DL, REPEAT = 1.130 NG/DL. (B)(6) 2024 SID (B)(6) INITIAL RESULT WAS >5.00 NG/DL, REPEAT = 1.030 NG/DL. (B)(6) 2024 SID (B)(6) INITIAL RESULT WAS >5.00 NG/DL, REPEAT = 0.830 NG/DL. (B)(6) 2024 SID (B)(6) INITIAL RESULT WAS >5.00 NG/DL, REPEAT = 1.100 NG/DL. (B)(6) 2024 SID (B)(6) INITIAL RESULT WAS >5.00 NG/DL, REPEAT = 1.480 NG/DL. (B)(6) 2024 SID (B)(6) INITIAL RESULT WAS >5.00 NG/DL, REPEAT = 0.790 NG/DL. (B)(6) 2024 SID (B)(6) INITIAL RESULT WAS >5.00 NG/DL, REPEAT = 1.910 NG/DL. (B)(6) 2024 SID (B)(6) INITIAL RESULT WAS >5.00 NG/DL, REPEAT = 1.300 NG/DL. (B)(6) 2024 SID (B)(6) INITIAL RESULT WAS >5.00 NG/DL, REPEAT WAS >5.00 NG/DL. (B)(6) 2024 SID (B)(6) INITIAL RESULT WAS >5.00 NG/DL, REPEAT = 0.960 NG/DL. (B)(6) 2024 SID (B)(6) INITIAL RESULT 2.11 NG/DL, REPEAT = 0.710 NG/DL. (B)(6) 2024 SID (B)(6) INITIAL RESULT WAS 3.68 NG/DL, REPEAT = 2.280 NG/DL. (B)(6) 2024 SID (B)(6) INITIAL RESULT WAS 2.47 NG/DL, REPEAT = 1.11 NG/DL. (B)(6) 2024 SID (B)(6) INITIAL RESULT WAS 1.88 NG/DL, REPEAT = 1.300 NG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1600367 ALINITY I FREE T4 REAGENT KIT RADIOIMMUNOASSAY, FREE THYROXINE CEC ABBOTT IRELAND DIAGNOSTICS DIVISION 57607UD00 00380740121822

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY I FREE T4 1200T, 07P70-30, 56201UD00| ALNTY I FREE T4 1200T, 07P70-30, 56201UD00| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)