ALINITY I FREE T4 REAGENT KIT

Additional Manufacturer Narrative

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

THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY I FREE T4 RESULTS FOR 34-YEAR-OLD PATIENT FEMALE PATIENT DIAGNOSED WITH THYROTOXICOSIS AND IS CURRENTLY UNDERGOING TREATMENT. THE FOLLOWING RESULTS WERE PROVIDED: (NORMAL RANGE: 9.01 - 19.05 PMOL/L) ON (B)(6) 2025, SID (B)(6), INITIAL FREE T4 RESULT = 18.58 PMOL/L, REPEAT RESULT = 18.68 PMOL/L, RESULT ON ROCHE COBAS = 28.92 PMOL/L (NORMAL RANGE: 12-22 PMOL/L) HISTORICAL RESULTS ON A DIFFERENT ANALYZER FREE T4 RESULT = 50.7 PMOL/L RESULTS FROM (B)(6) 2025 ON ALINITY FREE T4 RESULT = 42.77 PMOL/L ADDTIIONAL LAB RESULTS: TSH = < 0.0083 UIU/ML, FREE T3 = 9.170 PMOL/L, TRAB = 6.590 IU/L HISTORICAL RESULTS ON A DIFFERENT ANALYZER: TSH = 0.005 UIU/ML FREE T3 = 23.6 PMOL/L TRAB = 8.68 IU/L ANTI-TPO = 20.3 IU/ML RESULTS FROM (B)(6) 2025 ON ALINITY WITH REFERENCE RANGES: TSH = <0.0083 UIU/ML (0.350 - 4.940 UIU/ML) FREE T3 = >30.72 PMOL/L (2.427-6.006 PMOL/L) TRAB = 6.77 IU/L (<3.100 IU/L) ANTI-TPO = 13.9 IU/ML (< 5.61 IU/ML) THE CUSTOMER MENTIONED THEY ARE ONLY QUESTIONING THE FREE T4 RESULTS AS BEING INCORRECT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION FOR FALSE DEPRESSED 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 WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I FREE T4 ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 73276UD00. THE DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES, OR DEVIATIONS ASSOCIATED WITH THE LIST NUMBER. IN HOUSE ACCURACY TESTING OF THE RETAINED ANALYSIS OF ALINITY I FREE T4 REAGENT LOT 73276UD00 WAS PERFORMED. TESTING MET ACCEPTANCE CRITERIA AND THE PRODUCT IS PERFORMING AS EXPECTED. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I FREE T4 ASSAY FOR LOT 73276UD00 WAS IDENTIFIED. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY I FREE T4 RESULTS FOR 34-YEAR-OLD PATIENT FEMALE PATIENT DIAGNOSED WITH THYROTOXICOSIS AND IS CURRENTLY UNDERGOING TREATMENT. THE FOLLOWING RESULTS WERE PROVIDED: (NORMAL RANGE: 9.01 - 19.05 PMOL/L) (B)(6) 2025 SID (B)(6), INITIAL FREE T4 RESULT = 18.58 PMOL/L, REPEAT RESULT = 18.68 PMOL/L, RESULT ON ROCHE COBAS = 28.92 PMOL/L (NORMAL RANGE: 12-22 PMOL/L). HISTORICAL RESULTS ON A DIFFERENT ANALYZER FREE T4 RESULT = 50.7 PMOL/L. RESULTS FROM (B)(6) 2025 ON ALINITY FREE T4 RESULT = 42.77 PMOL/L. ADDTIIONAL LAB RESULTS: TSH = < 0.0083 UIU/ML, FREE T3 = 9.170 PMOL/L, TRAB = 6.590 IU/L HISTORICAL RESULTS ON A DIFFERENT ANALYZER: TSH = 0.005 UIU/ML, FREE T3 = 23.6 PMOL/L, TRAB = 8.68 IU/L, ANTI-TPO = 20.3 IU/ML. RESULTS FROM (B)(6) 2025 ON ALINITY WITH REFERENCE RANGES: TSH = <0.0083 UIU/ML (0.350 - 4.940 UIU/ML), FREE T3 = >30.72 PMOL/L (2.427-6.006 PMOL/L), TRAB = 6.77 IU/L (<3.100 IU/L), ANTI-TPO = 13.9 IU/ML (< 5.61 IU/ML) . THE CUSTOMER MENTIONED THEY ARE ONLY QUESTIONING THE FREE T4 RESULTS AS BEING INCORRECT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.