ALINITY I FREE T4 REAGENT KIT

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 = (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I FREE T4 RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE IS 9.0-19.05 PMOL/L): SAMPLE ID (B)(6) INITIAL RESULT, ON (B)(6) 2025, WAS >64.4 PMOL/L. IT WAS NOTED THAT THE FIRST AND THIRD TIME THE SAMPLE WAS RUN INSTRUMENT ERROR MESSAGES 3471 AND 3424 WERE GENERATED. THE SAMPLE VOLUME WAS TOO LOW TO REPEAT, SO A DIFFERENT SAMPLE WAS USED FOR REPEAT TESTING AND THE RESULT, ON (B)(6) 2025, WAS 13.7, REPEAT, ON ANOTHER ANALYZER, WAS 14.1 PMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION FOR A FALSELY ELEVATED ALINITY I FREE T4 RESULT 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 REAGENT LOT KIT, STORED AT THE RECOMMENDED STORAGE CONDITION. TESTING MET ACCEPTANCE CRITERIA, AND THE PRODUCTS ARE PERFORMING AS EXPECTED. REVIEW OF TRACKING AND TRENDING DATA IDENTIFIED AN INCREASE IN COMPLAINTS FOR THE ALINITY I FREE T4 ASSAY AS WELL AS AN INCREASE IN COMPLAINT ACTIVITY FOR REAGENT LOT 68382UD00. HOWEVER, TESTING WAS PERFORMED UTILIZING A RETAINED KIT OF LOT 68382UD00 AND NOTED THAT ALL TESTING PASSED, INDICATING THE REAGENT LOT IS 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 ALINITY I FREE T4, LOT NUMBER 68382UD00, WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I FREE T4 RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE IS 9.0-19.05 PMOL/L): SAMPLE ID (B)(6), INITIAL RESULT, ON (B)(6) 2025, WAS >64.4 PMOL/L. IT WAS NOTED THAT THE FIRST AND THIRD TIME THE SAMPLE WAS RUN INSTRUMENT ERROR MESSAGES 3471 AND 3424 WERE GENERATED. THE SAMPLE VOLUME WAS TOO LOW TO REPEAT, SO A DIFFERENT SAMPLE WAS USED FOR REPEAT TESTING AND THE RESULT, ON (B)(6) 2025, WAS 13.7, REPEAT, ON ANOTHER ANALYZER, WAS 14.1 PMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.