ALINITY I FREE T4 REAGENT KIT

Additional Manufacturer Narrative

CORRECTION TO LOT NUMBER IN SECTION H11 ADDITIONAL MFR NARRATIVE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A REVIEW OF TRACKING AND TRENDING DID IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. HOWEVER, NO COMMONALITIES FOR THE COMPLAINT LOT AND ISSUE WERE IDENTIFIED. IN-HOUSE TESTING WAS COMPLETED WITH A RETAINED KIT OF ALINITY I FREE T4 REAGENT LOT 76559UD00. TESTING MET ACCEPTANCE CRITERIA, AND THE PRODUCT IS PERFORMING AS EXPECTED. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT NUMBER. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I FREE T4 ASSAY, LOT 76559UD01 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I FREE T4 RESULT GENERATED FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 9.01-19.05 PMOL/L): INITIAL RESULT = 20.81 PMOL/L, REPEAT RESULT = 14.04 PMOL/L. OTHER RESULTS PROVIDED: TSH INITIAL RESULT = 0.7858 UIU/ML (REFERENCE RANGE 0.35-4.94 UIU/ML). FT3 INITIAL RESULT = 3.99 PMOL/L (REFERENCE RANGE 2.43-6.01 PMOL/L). 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 PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 9.01-19.05 PMOL/L): INITIAL RESULT = 20.81 PMOL/L, REPEAT RESULT = 14.04 PMOL/L. OTHER RESULTS PROVIDED: TSH INITIAL RESULT = 0.7858 UIU/ML (REFERENCE RANGE 0.35-4.94 UIU/ML). FT3 INITIAL RESULT = 3.99 PMOL/L (REFERENCE RANGE 2.43-6.01 PMOL/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A REVIEW OF TRACKING AND TRENDING DID IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. HOWEVER, NO COMMONALITIES FOR THE COMPLAINT LOT AND ISSUE WERE IDENTIFIED. IN-HOUSE TESTING WAS COMPLETED WITH A RETAINED KIT OF ALINITY I FREE T4 REAGENT LOT 76559UD00. TESTING MET ACCEPTANCE CRITERIA, AND THE PRODUCT IS PERFORMING AS EXPECTED. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT NUMBER. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I FREE T4 ASSAY, LOT 76559UD00 WAS IDENTIFIED.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION E1 - INITIAL REPORTER ESTABLISHMENT NAME COMPLETE ENTRY = (B)(6). SECTION E1 - ADDRESS 1 COMPLETE ENTRY = (B)6). 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 PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 9.01-19.05 PMOL/L): INITIAL RESULT = 20.81 PMOL/L, REPEAT RESULT = 14.04 PMOL/L OTHER RESULTS PROVIDED: TSH INITIAL RESULT = 0.7858 UIU/ML (REFERENCE RANGE 0.35-4.94 UIU/ML) FT3 INITIAL RESULT = 3.99 PMOL/L (REFERENCE RANGE 2.43-6.01 PMOL/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.