ALINITY I FREE T4 REAGENT KIT

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I FREE T4 RESULTS FOR MULTIPLE SAMPLES. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER PROVIDED REFERENCE RANGE: 0.70-1.48 NG/ML): SAMPLE 1: INITIAL RESULT = 2.02 NG/ML, REPEATS = 1.01 NG/ML AND 0.99 NG/ML, SAMPLE 2: INITIAL RESULT = 2.46 NG/ML, REPEAT = 1.12 NG/ML, SAMPLE 3: INITIAL RESULT =1.71 NG/ML, REPEAT = 1.28 NG/ML, NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, A SEARCH FOR SIMILAR COMPLAINTS, A TICKET TRENDING REVIEW, A DEVICE HISTORY RECORD REVIEW, A LABELING REVIEW, AND IN-HOUSE TESTING OF RETAINED REAGENT KIT. 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 73465UD01. 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 OR DEVIATIONS WITH LOT NUMBER 73465UD01 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 73465UD01.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I FREE T4 RESULTS FOR MULTIPLE SAMPLES. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER PROVIDED REFERENCE RANGE: 0.70-1.48 NG/ML): SAMPLE 1: INITIAL RESULT = 2.02 NG/ML, REPEATS = 1.01 NG/ML AND 0.99 NG/ML. SAMPLE 2: INITIAL RESULT = 2.46 NG/ML, REPEAT = 1.12 NG/ML. SAMPLE 3: INITIAL RESULT =1.71 NG/ML, REPEAT = 1.28 NG/ML. 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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P70-77 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07P70, 510K K173122.