ARCHITECT FREE T4

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT FREE T4 RESULTS GENERATED ON THE ARCHITECT I2000SR ANALYZER FOR MULTIPLE PATIENTS. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE: 11-17.7 PMOL/L): ON (B)(6) 2026, SID (B)(6) (32-YEAR-OLD, FEMALE): INITIAL FT4 RESULT = 20.44 PMOL/L, REPEAT FT4 RESULT = 9.3 PMOL/L, 2ND REPEAT RESULT = 9.76 PMOL/L. ON (B)(6) 2026, SID (B)(6) (32-YEAR-OLD, FEMALE): INITIAL FT4 RESULT = 26.69 PMOL/L, REPEAT RESULT = 11.77 PMOL/L. UPDATE: THE CUSTOMER PROVIDED ADDITIONAL PATIENT INFORMATION FOR FALSELY ELEVATED ARCHITECT FREE T4 (FT4) RESULTS. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER REFERENCE RANGE: 11-17.7 PMOL/L): ON (B)(6) 2026, 3-YEAR-OLD FEMALE IN THE PEDIATRIC CLINIC (PEDIATRIC REFERENCE RANGE: 11.45-17.63 PMOL/L). INITIAL FREE T4: 18.05 PMOL/L, REPEAT FREE T4: 14.74 PMOL/L. TESTED ON (B)(6) 2026: SAMPLE 1: SID (B)(6) (FEMALE, 21 YEARS OLD): INITIAL RESULT = 43.11 PMOL/L; REPEAT RESULT = 7.96 PMOL/L. SAMPLE 2: SID (B)(6) (FEMALE, 24 YEARS OLD): INITIAL RESULT = 24.4 PMOL/L; REPEAT RESULT = 9.54 PMOL/L. ON (B)(6) 2026, SID (B)(6) (34-YEAR-OLD): INITIAL RESULT = 37.72 PMOL/L; REPEAT RESULT = 14.74 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 FIELD DATA REVIEW. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. THE TICKET SEARCH BY LOT INDICATES THAT THE REAGENT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS REGARDING THE COMMONALITIES FOR THE COMPLAINT LOT AND ISSUE. A REVIEW IN THE CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) SYSTEM DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH COMPLAINT LOT AND COMPLAINT ISSUE. THE OVERALL PERFORMANCE OF ARCHITECT FREE T4 REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE MEDIAN PATIENT RESULTS FOR LOT 7458UD03 IS WITHIN ESTABLISHED LIMITS, INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY IN THE FIELD. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WITH THE ARCHITECT FREE T4 REAGENT FOR LOT 77458UD03 WAS IDENTIFIED. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7K65-78 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7K65, WITH 510K NUMBER K173122.