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 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 73465UD01. HOWEVER, TESTING PERFORMED USING RETAINED KITS FROM LOT 73465UD01 SHOWED THAT ALL RESULTS PASSED, INDICATING THE REAGENT LOT IS PERFORMING AS EXPECTED. A DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES, OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT OR ISSUE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I FREE T4 ASSAY, LOT 73465UD01 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY DECREASED ALINITY I FREE T4 RESULTS AND PROVIDED THE FOLLOWING DATA: THE FIRST SAMPLE WAS INITIALLY MEASURED AT <5.41PMOL/L, AND THE REPEAT RESULT WAS 13.26PMOL/ML. THE SECOND SAMPLE WAS INITIALLY MEASURED AT <5.41PMOL/L, AND THE REPEAT RESULT WAS 13.54PMOL/ML PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY DECREASED ALINITY I FREE T4 RESULTS AND PROVIDED THE FOLLOWING DATA: THE FIRST SAMPLE WAS INITIALLY MEASURED AT <5.41PMOL/L, AND THE REPEAT RESULT WAS 13.26PMOL/ML. THE SECOND SAMPLE WAS INITIALLY MEASURED AT <5.41PMOL/L, AND THE REPEAT RESULT WAS 13.54PMOL/ML. PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

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, WITH 510K NUMBER K173122. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION HAS BEEN INCLUDED. NO ADDITIONAL PATIENT DETAILS ARE AVAILABLE.