ALINITY I FREE T4 REAGENT KIT

Additional Manufacturer Narrative

THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A SEARCH FOR SIMILAR COMPLAINTS IDENTIFIED AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 76559UD01. ADDITIONALLY, A REVIEW OF TRACKING AND TRENDING DATA FOR THE ALINITY I FREE T4 ASSAY IDENTIFIED AN INCREASE IN COMPLAINTS. HOWEVER, IN-HOUSE PERFORMANCE TESTING WAS PERFORMED UTILIZING RETAINED REAGENT KIT OF THE COMPLAINT LOT. ALL TESTING PASSED, INDICATING THE REAGENT LOT IS PERFORMING AS EXPECTED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH LOT NUMBER 76559UD01 AND THE COMPLAINT ISSUE. A REVIEW OF LABELING WAS PERFORMED AND FOUND TO SUFFICIENTLY ADDRESS THE CUSTOMER'S ISSUE. BASED ON THIS INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ALINITY I FREE T4 REAGENT, LOT NUMBER 76559UD01.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I FREE T4 RESULT FOR TWO PATIENTS. RESULTS WERE NOT REPORTED TO MEDICAL PROVIDER. THE FOLLOWING DATA WAS PROVIDED: PATIENT 1= INITIAL RESULT = > 5.0 NG/DL. REPEAT RESULT = 1.07 NG/DL. PATIENT 2= (B)(6) 2026= INITIAL RESULT = 2.05 NG/DL, REPEAT RESULT 1.03 NG/DL. REFERENCE RANGE IS 0.70-1.48 NG/DL. NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I FREE T4 RESULT FOR TWO PATIENTS. RESULTS WERE NOT REPORTED TO MEDICAL PROVIDER. THE FOLLOWING DATA WAS PROVIDED: PATIENT 1= INITIAL RESULT = > 5.0 NG/DL. REPEAT RESULT = 1.07 NG/DL PATIENT 2= (B)(6) 2026= INITIAL RESULT = 2.05 NG/DL, REPEAT RESULT 1.03 NG/DL. REFERENCE RANGE IS 0.70-1.48 NG/DL. NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. ALL AVAILABLE PATIENT INFORMATION WAS AVAILABLE, NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P70, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US WITH THE SAME LIST NUMBER, AND A 510K/PMA/BLA NUMBER OF K173122.