ALINITY I FREE T4 REAGENT KIT

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 K173122, WITH 510K/PMA/BLA NUMBER K173122. 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 OF RETAINED REAGENT KIT. THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A SEARCH FOR SIMILAR COMPLAINTS IDENTIFIED AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 71598UD01. ADDITIONALLY, A REVIEW OF TRACKING AND TRENDING DATA FOR THE ALINITY I FREE T4 ASSAY IDENTIFIED AN INCREASE IN COMPLAINTS. HOWEVER, IN-HOUSE PERFORMANCE TESTING WAS PERFORMED UTILIZING RETAINED REAGENT KIT OF THE COMPLAINT LOT. ALL TESTING PASSED INDICATING THE REAGENT LOT IS PERFORMING AS EXPECTED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH LOT NUMBER 71598UD01 AND THE COMPLAINT ISSUE. A REVIEW OF LABELING WAS PERFORMED AND FOUND TO SUFFICIENTLY ADDRESS THE CUSTOMER'S ISSUE. BASED ON THIS INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ALINITY I FREE T4 REAGENT, LOT NUMBER 71598UD01.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 FOR MULTIPLE PATIENTS THAT WERE NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 9.01-19.05 PMOL/L): SAMPLE 1, INITIAL FREE T4 RESULT= 27.40 PMOL/L; REPEAT RESULT= 14.13 PMOL/L, SAMPLE 2, INITIAL FREE T4 RESULT= 19.55 PMOL/L; REPEAT RESULT= 12.63 PMOL/L, SAMPLE 3, INITIAL FREE T4 RESULT >64.35 PMOL/L; REPEAT RESULT= 11.14 PMOL/L, SAMPLE 4, INITIAL FREE T4 RESULT= 58.83 PMOL/L; REPEAT RESULT= 17.24 PMOL/L . THERE WAS NO IMPACT TO PATIENT MANAGEMENT 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 FOR MULTIPLE PATIENTS THAT WERE NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 9.01-19.05 PMOL/L): SAMPLE 1, INITIAL FREE T4 RESULT= 27.40 PMOL/L; REPEAT RESULT= 14.13 PMOL/L. SAMPLE 2, INITIAL FREE T4 RESULT= 19.55 PMOL/L; REPEAT RESULT= 12.63 PMOL/L. SAMPLE 3, INITIAL FREE T4 RESULT >64.35 PMOL/L; REPEAT RESULT= 11.14 PMOL/L. SAMPLE 4, INITIAL FREE T4 RESULT= 58.83 PMOL/L; REPEAT RESULT= 17.24 PMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.