ARCHITECT FREE T4

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A1 - PATIENT IDENTIFIER COMPLETE ENTRY = CASE 1 AND CASE 2 ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT FREE T4 RESULTS FOR TWO PATIENTS. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE IS 0.7-1.48 NG/DL): CASE 1 INITIAL RESULT WAS 1.65, REPEAT RESULT WAS 1.39 NG/DL CASE 2 INITIAL RESULT WAS 1.78, REPEAT RESULT WAS 1.3 NG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION FOR FALSELY ELEVATED ARCHITECT FREE T4 RESULTS INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, THE REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELING, DEVICE HISTORY RECORDS, AND TESTING OF RETAINED REAGENT KIT. ACCURACY TESTING WAS PERFORMED USING PANELS, WHICH MIMICS PATIENT SAMPLES, AND AN IN-HOUSE RETAINED KIT OF LOT 68900UD02, STORED AT THE RECOMMENDED STORAGE CONDITION. THE TESTING WAS COMPLETED INDICATING THAT THE PRODUCT IS PERFORMING AS EXPECTED. A REVIEW OF TRACKING AND TRENDING DID IDENTIFY TRENDS FOR LIST NUMBER 07K65. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS IDENTIFIED FOR REAGENT LOT 68900UD02. HOWEVER, TESTING WAS PERFORMED AND ALL TESTING PASSED INDICATING THE REAGENT LOTS ARE PERFORMING AS EXPECTED. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS FOR THE LIKELY CAUSE LOT AND COMPLAINT ISSUE. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LOT WAS REVIEWED AND DID NOT IDENTIFY ANY ISSUES. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INFORMATION PROVIDED AND ABBOTT DIAGNOSTICS¿ COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF ARCHITECT FREE T4, LOT NUMBER 68900UD02, WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT FREE T4 RESULTS FOR TWO PATIENTS. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE IS 0.7-1.48 NG/DL): CASE 1 INITIAL RESULT WAS 1.65, REPEAT RESULT WAS 1.39 NG/DL. CASE 2 INITIAL RESULT WAS 1.78, REPEAT RESULT WAS 1.3 NG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.