BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I FREE T4 REAGENT KIT

    MDR report key: 20449854 · Received October 15, 2024

    Report

    Report Number
    3005094123-2024-00533
    Event Type
    Malfunction
    Date Received
    October 15, 2024
    Date of Event
    September 2, 2024
    Report Date
    November 15, 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

    THE COMPLAINT INVESTIGATION FOR FALSELY ELEVATED ALINITY I FREE T4 RESULTS 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. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. RETURN TESTING WAS NOT PERFORMED AS RETURNS WERE NOT AVAILABLE. AN INCREASE IN COMPLAINTS HAS BEEN OBSERVED FOR LOT 60071UD00, HOWEVER, IN-HOUSE PERFORMANCE WAS COMPLETED WHICH INDICATES THE PRODUCT IS PERFORMING AS EXPECTED. THE DEVICE HISTORY RECORD REVIEW DID NOT SHOW ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES, OR DEVIATIONS ASSOCIATED WITH THE LOT NUMBER AND COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I FREE T4 FOR LOT NUMBER 60071UD00 WAS IDENTIFIED. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    SECTION A1 PATIENT IDENTIFIER COMPLETE INFORMATION: (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 RESULTS FOR MULTIPLE SAMPLES. THE FOLLOWING RESULTS WERE PROVIDED: (CUSTOMER PROVIDED REFERENCE RANGE 0.7 - 1.48 NG/DL): (B)(6) 2024 SID (B)(6) (LOT 60071UD00) INITIAL RESULT 2.21 NG/DL, REPEAT 1.46 NG/DL, PATIENT DIAGNOSIS PAPILLARY THYROID CARCINOMA, ADDITIONAL LAB RESULTS T3 0.76, TSH 1.8722. (B)(6) 2024 SID (B)(6) (LOT 60071UD00) INITIAL RESULT 1.32 NG/DL, REPEAT 1.57 NG/DL, PATIENT DIAGNOSIS HYPOTHYROIDISM, ADDITIONAL LAB RESULTS T3 1.09, TSH 0.3746. (B)(6) 2024 SID (B)(6) (LOT 60071UD00) INITIAL RESULT 1.55 NG/DL, REPEAT 1.30 NG/DL, PATIENT DIAGNOSIS HYPONATREMIA, ADDITIONAL LAB RESULTS T3 0.43, TSH 5.4047. (B)(6) 2024 SID (B)(6) (LOT 60071UD00) INITIAL RESULT >5.00 NG/DL, REPEATS >5.00 NG/DL, 1.00 NG/DL, PATIENT DIAGNOSIS PAPILLARY THYROID CARCINOMA, ADDITIONAL LAB RESULTS T3 0.67, TSH 2.5265. (B)(6) 2024 SID (B)(6) (LOT 60071UD00) INITIAL RESULT 1.74 NG/DL, REPEAT 1.43 NG/DL, PATIENT DIAGNOSIS PAPILLARY THYROID CARCINOMA, ADDITIONAL LAB RESULTS T3 0.7, TSH 6.6211, A-TG <0.9. (B)(6) 2024 SID (B)(6) (LOT 60071UD00) INITIAL RESULT 1.46 NG/DL, REPEAT 0.94 NG/DL, PATIENT DIAGNOSIS HYPERTHYROIDISM, WITH THYROTOXIC CRISIS OR STORM, ADDITIONAL LAB RESULTS T3 0.87, TSH 1.7753. (B)(6) 2024 SID (B)(6) (LOT 60071UD00) INITIAL RESULT 1.66 NG/DL, REPEAT 1.36 NG/DL, PATIENT DIAGNOSIS HYPOTHYROIDISM, ADDITIONAL LAB RESULTS T3 0.85, TSH 3.1895. (B)(6) 2024 SID (B)(6) (LOT 60071UD00) INITIAL RESULT 1.61 NG/DL, REPEAT 1.24 NG/DL, PATIENT DIAGNOSIS HYPERPIGMENTATION, ADDITIONAL LAB RESULTS T3 1.05, TSH 2.5868. (B)(6) 2024 SID (B)(6) (LOT 60071UD00) INITIAL RESULT 1.88 NG/DL, REPEAT 1.31 NG/DL, PATIENT DIAGNOSIS PAPILLARY THYROID CARCINOMA, HYPERCALCEMIA, ADDITIONAL LAB RESULTS T3 0.85, TSH 0.5246, A-TG 0.91. (B)(6) 2024 SID (B)(6) (LOT 60071UD00) INITIAL RESULT 1.63 NG/DL, REPEAT 1.15 NG/DL, PATIENT DIAGNOSIS PAPILLARY THYROID CARCINOMA, ADDITIONAL LAB RESULTS T3 0.74, TSH 0.0093. (B)(6) 2024 SID (B)(6) (LOT 60071UD00) INITIAL RESULT 1.55 NG/DL, REPEAT 1.17 NG/DL, PATIENT DIAGNOSIS HYPOTHYROIDISM, ADDITIONAL LAB RESULTS T3 0.74, TSH 1.6785. (B)(6) 2024 SID (B)(6) (LOT 60071UD00) INITIAL RESULT >5.0 NG/DL, REPEAT 1.19 NG/DL, PATIENT DIAGNOSIS OTHER OSTEOPOROSIS WITH PATHOLOGICAL FRACTURE, ADDITIONAL LAB RESULTS TSH 2.5709. (B)(6) 2024 SID (B)(6) (LOT 60071UD00) INITIAL RESULT 2.26 NG/DL, REPEAT 1.22 NG/DL, PATIENT DIAGNOSIS OTHER OSTEOPOROSIS WITH PATHOLOGICAL FRACTURE, ADDITIONAL LAB RESULTS T3 0.88, TSH 0.4906, A-TG <0.9. (B)(6) 2024 SID (B)(6) (LOT 60071UD00) INITIAL RESULT 1.99 NG/DL, REPEAT 0.90 NG/DL, PATIENT DIAGNOSIS THYROID HORMONE TESTS ABNORMALITY, ADDITIONAL LAB RESULTS T3 1.01, TSH 2.3534. (B)(6) 2024 SID (B)(6) (LOT 60071UD00) INITIAL RESULT >5.0 NG/DL, (LOT 65500UD00) REPEAT 1.11 NG/DL, PATIENT DIAGNOSIS CHRONIC URTICARIA, ADDITIONAL LAB RESULTS T3 1.0, TSH 0.4077. (B)(6) 2024 SID (B)(6) (LOT 60071UD00) INITIAL RESULT >5.0 NG/DL, REPEATS >5.0 NG/DL, (LOT 65500UD00) 1.11 NG/DL, PATIENT DIAGNOSIS THYROID NODULE HYPOTHYROIDISM, HASHIMOTO'S THYROIDITIS, ADDITIONAL LAB RESULTS T3 1.13, TSH 2.2567. (B)(6) 2024 SID (B)(6) (LOT 60071UD00) INITIAL RESULT 1.86 NG/DL, REPEAT 1.31 NG/DL, PATIENT DIAGNOSIS HYPERTENSIVE HEART FAILURE, ADDITIONAL LAB RESULTS T3 1.09, TSH 0.479. 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. THE FOLLOWING RESULTS WERE PROVIDED: (CUSTOMER PROVIDED REFERENCE RANGE 0.7 - 1.48 NG/DL) (B)(6) 2024 SID (B)(6) (LOT 60071UD00) INITIAL RESULT 2.21 NG/DL, REPEAT 1.46 NG/DL, PATIENT DIAGNOSIS PAPILLARY THYROID CARCINOMA, ADDITIONAL LAB RESULTS T3 0.76, TSH 1.8722. (B)(6) 2024 SID (B)(6) (LOT 60071UD00) INITIAL RESULT 1.32 NG/DL, REPEAT 1.57 NG/DL, PATIENT DIAGNOSIS HYPOTHYROIDISM, ADDITIONAL LAB RESULTS T3 1.09, TSH 0.3746. (B)(6) 2024 SID (B)(6) (LOT 60071UD00) INITIAL RESULT 1.55 NG/DL, REPEAT 1.30 NG/DL, PATIENT DIAGNOSIS HYPONATREMIA, ADDITIONAL LAB RESULTS T3 0.43, TSH 5.4047. (B)(6) 2024 SID (B)(6) (LOT 60071UD00) INITIAL RESULT >5.00 NG/DL, REPEATS >5.00 NG/DL, 1.00 NG/DL, PATIENT DIAGNOSIS PAPILLARY THYROID CARCINOMA, ADDITIONAL LAB RESULTS T3 0.67, TSH 2.5265. (B)(6) 2024 SID (B)(6) (LOT 60071UD00) INITIAL RESULT 1.74 NG/DL, REPEAT 1.43 NG/DL, PATIENT DIAGNOSIS PAPILLARY THYROID CARCINOMA, ADDITIONAL LAB RESULTS T3 0.7, TSH 6.6211, A-TG <0.9. (B)(6) 2024 SID (B)(6) (LOT 60071UD00) INITIAL RESULT 1.46 NG/DL, REPEAT 0.94 NG/DL, PATIENT DIAGNOSIS HYPERTHYROIDISM, WITH THYROTOXIC CRISIS OR STORM, ADDITIONAL LAB RESULTS T3 0.87, TSH 1.7753. (B)(6) 2024 SID (B)(6) (LOT 60071UD00) INITIAL RESULT 1.66 NG/DL, REPEAT 1.36 NG/DL, PATIENT DIAGNOSIS HYPOTHYROIDISM, ADDITIONAL LAB RESULTS T3 0.85, TSH 3.1895. (B)(6)2024 SID (B)(6) (LOT 60071UD00) INITIAL RESULT 1.61 NG/DL, REPEAT 1.24 NG/DL, PATIENT DIAGNOSIS HYPERPIGMENTATION, ADDITIONAL LAB RESULTS T3 1.05, TSH 2.5868. (B)(6) 2024 SID (B)(6) (LOT 60071UD00) INITIAL RESULT 1.88 NG/DL, REPEAT 1.31 NG/DL, PATIENT DIAGNOSIS PAPILLARY THYROID CARCINOMA, HYPERCALCEMIA, ADDITIONAL LAB RESULTS T3 0.85, TSH 0.5246, A-TG 0.91. (B)(6) 2024 SID (B)(6) (LOT 60071UD00) INITIAL RESULT 1.63 NG/DL, REPEAT 1.15 NG/DL, PATIENT DIAGNOSIS PAPILLARY THYROID CARCINOMA, ADDITIONAL LAB RESULTS T3 0.74, TSH 0.0093. (B)(6) 2024 SID (B)(6) (LOT 60071UD00) INITIAL RESULT 1.55 NG/DL, REPEAT 1.17 NG/DL, PATIENT DIAGNOSIS HYPOTHYROIDISM, ADDITIONAL LAB RESULTS T3 0.74, TSH 1.6785. (B)(6) 2024 SID (B)(6) (LOT 60071UD00) INITIAL RESULT >5.0 NG/DL, REPEAT 1.19 NG/DL, PATIENT DIAGNOSIS OTHER OSTEOPOROSIS WITH PATHOLOGICAL FRACTURE, ADDITIONAL LAB RESULTS TSH 2.5709. (B)(6) 2024 SID (B)(6) (LOT 60071UD00) INITIAL RESULT 2.26 NG/DL, REPEAT 1.22 NG/DL, PATIENT DIAGNOSIS OTHER OSTEOPOROSIS WITH PATHOLOGICAL FRACTURE, ADDITIONAL LAB RESULTS T3 0.88, TSH 0.4906, A-TG <0.9. (B)(6) 2024 SID (B)(6) (LOT 60071UD00) INITIAL RESULT 1.99 NG/DL, REPEAT 0.90 NG/DL, PATIENT DIAGNOSIS THYROID HORMONE TESTS ABNORMALITY, ADDITIONAL LAB RESULTS T3 1.01, TSH 2.3534. (B)(6) 2024 SID (B)(6) (LOT 60071UD00) INITIAL RESULT >5.0 NG/DL, (LOT 65500UD00) REPEAT 1.11 NG/DL, PATIENT DIAGNOSIS CHRONIC URTICARIA, ADDITIONAL LAB RESULTS T3 1.0, TSH 0.4077. (B)(6) 2024 SID (B)(6) (LOT 60071UD00) INITIAL RESULT >5.0 NG/DL, REPEATS >5.0 NG/DL, (LOT 65500UD00) 1.11 NG/DL, PATIENT DIAGNOSIS THYROID NODULE HYPOTHYROIDISM, HASHIMOTO'S THYROIDITIS, ADDITIONAL LAB RESULTS T3 1.13, TSH 2.2567. (B)(6) 2024 SID (B)(6) (LOT 60071UD00) INITIAL RESULT 1.86 NG/DL, REPEAT 1.31 NG/DL, PATIENT DIAGNOSIS HYPERTENSIVE HEART FAILURE, ADDITIONAL LAB RESULTS T3 1.09, TSH 0.479. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361172 ALINITY I FREE T4 REAGENT KIT RADIOIMMUNOASSAY, FREE THYROXINE CEC ABBOTT IRELAND DIAGNOSTICS DIVISION 60071UD00 00380740121822

    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)