ALINITY I FREE T4 REAGENT KIT

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION FOR FALSELY ELEVATED ALINITY I FREE T4 RESULTS INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, THE REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELING, AND DEVICE HISTORY RECORDS. A REVIEW OF TRACKING AND TRENDING DID IDENTIFY AN INCREASE IN COMPLAINTS FOR LIST NUMBER 07P70, HOWEVER, NO TRENDS WERE IDENTIFIED FOR THE COMPLAINT LOT. THE OVERALL PERFORMANCE OF THE ALINITY I FREE T4 REAGENTS IN THE FIELD WAS REVIEWED USING WORLDWIDE FIELD DATA. THE REVIEW SHOWS THAT THE RESULT FOR THE MEDIAN POPULATION IS WITHIN ESTABLISHED LIMITS, INDICATING THE REAGENT LOT IS PERFORMING ACCEPTABLY ON MARKET. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS FOR THE LOT AND COMPLAINT ISSUE. MANUFACTURING DOCUMENTATION FOR THE 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 ALINITY I FREE T4, LOT NUMBER 82220UD00, WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I FREE T4 RESULT FOR AN 80-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE IS 9-19 PMOL/L): SAMPLE ID (B)(6), INITIAL RESULT, ON 01MAR, WAS 47.1, REPEAT RESULT, ON ANOTHER ANALYZER, WAS 17.8 PMOL/L. IT WAS NOTED THAT THE FIRST TIME THE SAMPLE WAS TESTED THERE WAS AN ASPIRATION ERROR. 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. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION.

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I FREE T4 RESULT FOR AN 80-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE IS 9-19 PMOL/L): SAMPLE ID (B)(6) INITIAL RESULT, ON (B)(6), WAS 47.1, REPEAT RESULT, ON ANOTHER ANALYZER, WAS 17.8 PMOL/L. IT WAS NOTED THAT THE FIRST TIME THE SAMPLE WAS TESTED THERE WAS AN ASPIRATION ERROR. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.