ALINITY I FREE T4 REAGENT KIT

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. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. REVIEW OF TRACKING AND TRENDING DATA FOR THE ALINITY I FREE T4 ASSAY DID IDENTIFY AN INCREASE IN COMPLAINTS. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS IDENTIFIED FOR REAGENT LOT 79271UD01; HOWEVER, IN-HOUSE ACCURACY TESTING WAS COMPLETED WITH A RETAINED KIT OF THE COMPLAINT LOT. TESTING MET ACCEPTANCE CRITERIA AND THE PRODUCT IS PERFORMING AS EXPECTED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NONCONFORMANCES, OR DEVIATIONS WITH LOT NUMBER AND THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE. BASED ON THIS INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ALINITY I FREE T4 REAGENT, LOT NUMBER 79271UD01.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I FREE T4 AND PROVIDED THE FOLLOWING DATA FOR A 56 YEAR OLD FEMALE: SAMPLE ID (B)(6) INITIAL MEASUREMENT WAS >64 PMOL/L, RETEST RESULTS WERE 23.38 & 11.6 PMOL/L. THYROID FUNCTION AND OTHER RESULTS WERE NORMAL. (CUSTOMER REFERENCE RANGE IS 9.01-19.05 PMOL/L). 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 7P70, WITH 510K/PMA/BLA NUMBER K173122. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I FREE T4 AND PROVIDED THE FOLLOWING DATA FOR A 56 YEAR OLD FEMALE: SAMPLE ID (B)(6) INITIAL MEASUREMENT WAS >64 PMOL/L, RETEST RESULTS WERE 23.38 & 11.6 PMOL/L. THYROID FUNCTION AND OTHER RESULTS WERE NORMAL. (CUSTOMER REFERENCE RANGE IS 9.01-19.05 PMOL/L). PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.