ALINITY I FREE T4 REAGENT KIT

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FINAL 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, 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 OBSERVED A FALSELY ELEVATED ALINITY I FREE T4 RESULT GENERATED FOR A 77-YEAR-OLD MALE PATIENT SAMPLE DIAGNOSED WITH HYPOTHYROIDISM. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 9.01-19.05 PMOL/L): SAMPLE ID (B)(6), INITIAL RESULT = 19.75 PMOL/L, REPEAT RESULTS = 16.59 PMOL/L, 16.62 PMOL/L. OTHER RESULTS PROVIDED THAT THE CUSTOMER IS NOT QUESTIONING: TSH INITIAL RESULT = 0.7698 UIU/ML, REPEAT RESULT = 0.7712 UIU/ML . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I FREE T4 RESULT GENERATED FOR A 77-YEAR-OLD MALE PATIENT SAMPLE DIAGNOSED WITH HYPOTHYROIDISM. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 9.01-19.05 PMOL/L): SAMPLE ID (B)(6) INITIAL RESULT = 19.75 PMOL/L, REPEAT RESULTS = 16.59 PMOL/L, 16.62 PMOL/L. OTHER RESULTS PROVIDED THAT THE CUSTOMER IS NOT QUESTIONING: TSH INITIAL RESULT = 0.7698 UIU/ML, REPEAT RESULT = 0.7712 UIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT 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 75641UD00. HOWEVER, TESTING WAS PERFORMED UTILIZING RETAINED KIT OF LOT 75641UD00 AND NOTED THAT ALL TESTING PASSED, INDICATING THE REAGENT LOT IS PERFORMING AS EXPECTED. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT NUMBER OR ISSUE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I FREE T4 ASSAY, LOT 75641UD00 WAS IDENTIFIED.