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. A1: PATIENT IDENTIFIER: (B)(6) (2 TOTAL PATIENTS). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY DECREASED ALINITY I FREE T4 RESULTS FOR MULTIPLE PATIENT SAMPLES GENERATED ON THE ALINITY I AM PROCESSING MODULE. THE CUSTOMER DID A PATIENT COMPARISON AS PART OF INVESTIGATING THE ISSUE OF UNDER RECOVERING FREE T4 RESULTS. THE CUSTOMER BELIEVES THE ORIGINAL RESULT RUN ON (B)(6) ARE THE CORRECT RESULTS AND WERE RELEASED TO THE CLINICAL PHYSICIAN. THE ORIGINAL RESULT RUN ON (B)(6) (ALCI-3); ON (B)(6) 2025, REPEAT RESULT RUN ON (B)(6) (ALCI-4): SID: (B)(6): ORIGINAL RESULT = 33.0 PMOL/L; REPEAT RESULT = 20.32 PMOL/L. SID: (B)(6): ORIGINAL RESULT = 22.6 PMOL/L; REPEAT RESULT = 15.3 PMOL/L. THE CUSTOMER TOOK SAMPLE ID: (B)(6) AND RAN 5 REPLICATES OF FREE T4 AND GOT THE FOLLOWING RESULTS: 18.7 / > 64.35 / 20.4 / 19.68 / 21.45 PMOL/L. THE CUSTOMER¿S NORMAL REFERENCE RANGE IS 9.0 - 22.0 PMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY DECREASED ALINITY I FREE T4 RESULTS FOR MULTIPLE PATIENT SAMPLES GENERATED ON THE ALINITY I PROCESSING MODULE. THE CUSTOMER DID A PATIENT COMPARISON AS PART OF INVESTIGATING THE ISSUE OF UNDER RECOVERING FREE T4 RESULTS. THE CUSTOMER BELIEVES THE ORIGINAL RESULT RUN ON (B)(6) ARE THE CORRECT RESULTS AND WERE RELEASED TO THE CLINICAL PHYSICIAN. THE ORIGINAL RESULT RUN ON (B)(6) (ALCI-3); ON (B)(6) 2025, REPEAT RESULT RUN ON (B)(6) (ALCI-4): SID B.(B)(6).H: ORIGINAL RESULT = 33.0 PMOL/L; REPEAT RESULT = 20.32 PMOL/L. SID B.(B)(6).T: ORIGINAL RESULT = 22.6 PMOL/L; REPEAT RESULT = 15.3 PMOL/L. THE CUSTOMER TOOK SAMPLE ID B.(B)(6) .H AND RAN 5 REPLICATES OF FREE T4 AND GOT THE FOLLOWING RESULTS: 18.7 / > 64.35 / 20.4 / 19.68 / 21.45 PMOL/L. THE CUSTOMER¿S NORMAL REFERENCE RANGE IS 9.0 - 22.0 PMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

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 RETAINED REAGENT KIT LOT 76559UD00. 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 ANY TRENDS RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, NO TRENDS WERE IDENTIFIED FOR LOT 76559UD00. TESTING WAS PERFORMED UTILIZING A RETAINED KIT OF THE COMPLAINT LOT AND NOTED THAT ALL TESTING PASSED, INDICATING THE REAGENT LOT IS PERFORMING AS EXPECTED. A REVIEW IN THE CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) SYSTEM DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT AND COMPLAINT ISSUE. THE PRODUCT LABELING PROVIDES APPROPRIATE INFORMATION RELATED TO THE CUSTOMER ISSUE, WHICH ASSISTS THEM IN RESOLVING THEIR ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY OF THE ALINITY I FREE T4 REAGENT LOT 76559UD00 WAS IDENTIFIED.