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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 RESULTS FOR TWO PATIENT SAMPLES. THE FOLLOWING RESULTS WERE PROVIDED: (FT4 REFERENCE RANGE: 9.01-19.05 PMOL/L). INITIAL RESULT = >64.35 PMOL/L, REPEAT RESULT = 14.12 PMOL/L. INITIAL RESULT = 28.12 PMOL/L, REPEAT RESULT = 11.50 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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 RESULTS FOR TWO PATIENT SAMPLES. THE FOLLOWING RESULTS WERE PROVIDED: (FT4 REFERENCE RANGE: 9.01-19.05 PMOL/L). INITIAL RESULT = >64.35 PMOL/L, REPEAT RESULT = 14.12 PMOL/L INITIAL RESULT = 28.12 PMOL/L, REPEAT RESULT = 11.50 PMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.