ALINITY I FREE T4 REAGENT KIT

Additional Manufacturer Narrative

COMPLETE ENTRY FOR SECTION A1: PATIENT IDENTIFIER: (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

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 9.0 - 19.0 PMOL/L): ON (B)(6) 2025, SID: (B)(6), INITIAL FREE T4 RESULT (B)(6) LOT: 71598UD00) >64.35 PMOL/L; REPEAT RESULT (B)(6) LOT: 75088UD00)14.5642 PMOL/L, 14.5827 PMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

D10 - CONCOMITANT PRODUCT CORRECTED. THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, DEVICE HISTORY RECORD REVIEW, IN HOUSE TESTING AND LABELING REVIEW. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. REVIEW OF TRACKING AND TRENDING DATA FOR THE ALINITY I FREE T4 ASSAY DID IDENTIFY AN INCREASE IN COMPLAINTS. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS IDENTIFIED FOR REAGENT LOT 71598UD00. HOWEVER, IN HOUSE TESTING WAS PERFORMED UTILIZING RETAINED KITS OF LOT 71598UD00. ALL TESTING PASSED INDICATING THE REAGENT LOT IS PERFORMING AS EXPECTED. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT NUMBERS AND COMPLAINT ISSUE. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I FREE T4 REAGENT LOTS 71598UD00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 9.0 - 19.0 PMOL/L): ON (B)(6) 2025, SID (B)(6), INITIAL FREE T4 RESULT (B)(6) LOT 71598UD00) >64.35 PMOL/L; REPEAT RESULT ( (B)(6) LOT 75088UD00)= 14.5642 PMOL/L, 14.5827 PMOL/L . THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.