ALINITY I FREE T4 REAGENT KIT

Additional Manufacturer Narrative

DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. A REVIEW OF TRACKING AND TRENDING DATA IDENTIFIED AN INCREASE IN COMPLAINTS FOR THE ALINITY I FREE T4 ASSAY AS WELL AS AN INCREASE IN COMPLAINT ACTIVITY FOR REAGENT LOT 76559UD01. HOWEVER, TESTING WAS PERFORMED UTILIZING RETAINED KITS OF LOT 76559UD00 AND NOTED THAT ALL TESTING PASSED, INDICATING THE REAGENT LOTS ARE PERFORMING AS EXPECTED. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT AND COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE. PER THE LIMITATIONS OF THE PROCEDURE SECTION OF THE PACKAGE INSERT, RESULTS SHOULD BE USED IN CONJUNCTION WITH OTHER DATA, E.G., SYMPTOMS, RESULTS OF OTHER THYROID TESTS, CLINICAL IMPRESSIONS, ETC. IF THE FREE T4 RESULTS ARE INCONSISTENT WITH CLINICAL EVIDENCE, ADDITIONAL TESTING IS SUGGESTED TO CONFIRM THE RESULT. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I FREE T4 ASSAY, LOT 76559UD01 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I FREE T4 RESULT FOR ONE PATIENT. THE SAMPLE WAS REPEATED WITH A LOWER RESULT. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT = 29 REPEAT RESULT = 13 PMOL/L. REFERENCE RANGE IS 9.01-19.05 PMOL/L 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. 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.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I FREE T4 RESULT FOR ONE PATIENT. THE SAMPLE WAS REPEATED WITH A LOWER RESULT. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT = 29 REPEAT RESULT = 13 PMOL/L. REFERENCE RANGE IS 9.01-19.05 PMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.