ALINITY I FREE T4 REAGENT KIT

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD 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 73465UD01. HOWEVER, IN HOUSE TESTING WAS PERFORMED UTILIZING RETAINED KIT OF LOT 73465UD00. ALL ACCEPTANCE CRITERIA WERE MET, DEMONSTRATING THAT THE LOT IS PERFORMING AS EXPECTED. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES, OR DEVIATIONS ASSOCIATED WITH THE LIKELY CAUSE LIST NUMBER. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I FREE T4 REAGENT LOT 73465UD01 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 RESULTS GENERATED FOR MULTIPLE PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 9.01-19.05 PMOL/L): INITIAL RESULT = 20.08 PMOL/L, REPEAT RESULT = 14.67 PMOL/L. INITIAL RESULT = 21.17 PMOL/L, REPEAT RESULT = 13.75 PMOL/L. INITIAL RESULT = 27.07 PMOL/L, REPEAT RESULT = 16.33 PMOL/L. INITIAL RESULT = 22.37 PMOL/L, REPEAT RESULT = 15.06 PMOL/L. INITIAL RESULT = 21.02 PMOL/L, REPEAT RESULT = 13.55 PMOL/L. INITIAL RESULT = 20.79 PMOL/L, REPEAT RESULT = 14.38 PMOL/L. INITIAL RESULT = 30.00 PMOL/L, REPEAT RESULT = 15.04 PMOL/L. INITIAL RESULT = 21.09 PMOL/L, REPEAT RESULT = 13.22 PMOL/L. INITIAL RESULT = 21.28 PMOL/L, REPEAT RESULT = 14.09 PMOL/L. INITIAL RESULT = >64.35 PMOL/L, REPEAT RESULT = 18.56 PMOL/L. INITIAL RESULT = 21.80 PMOL/L, REPEAT RESULT = 16.10 PMOL/L. INITIAL RESULT = 31.81 PMOL/L, REPEAT RESULT = 13.38 PMOL/L. INITIAL RESULT = >64.35 PMOL/L, REPEAT RESULT = 13.27 PMOL/L. INITIAL RESULT = >64.35 PMOL/L, REPEAT RESULT = 12.39 PMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

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 FALSELY ELEVATED ALINITY I FREE T4 RESULTS GENERATED FOR MULTIPLE PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 9.01-19.05 PMOL/L): INITIAL RESULT = 20.08 PMOL/L, REPEAT RESULT = 14.67 PMOL/L. INITIAL RESULT = 21.17 PMOL/L, REPEAT RESULT = 13.75 PMOL/L. INITIAL RESULT = 27.07 PMOL/L, REPEAT RESULT = 16.33 PMOL/L. INITIAL RESULT = 22.37 PMOL/L, REPEAT RESULT = 15.06 PMOL/L. INITIAL RESULT = 21.02 PMOL/L, REPEAT RESULT = 13.55 PMOL/L. INITIAL RESULT = 20.79 PMOL/L, REPEAT RESULT = 14.38 PMOL/L. INITIAL RESULT = 30.00 PMOL/L, REPEAT RESULT = 15.04 PMOL/L. INITIAL RESULT = 21.09 PMOL/L, REPEAT RESULT = 13.22 PMOL/L. INITIAL RESULT = 21.28 PMOL/L, REPEAT RESULT = 14.09 PMOL/L. INITIAL RESULT = >64.35 PMOL/L, REPEAT RESULT = 18.56 PMOL/L. INITIAL RESULT = 21.80 PMOL/L, REPEAT RESULT = 16.10 PMOL/L. INITIAL RESULT = 31.81 PMOL/L, REPEAT RESULT = 13.38 PMOL/L. INITIAL RESULT = >64.35 PMOL/L, REPEAT RESULT = 13.27 PMOL/L. INITIAL RESULT = >64.35 PMOL/L, REPEAT RESULT = 12.39 PMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.