ALINITY I FREE T4 REAGENT KIT

Additional Manufacturer Narrative

ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P70-77 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P70, WITH 510K/PMA/BLA NUMBER K173122.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I FREE T4 RESULT FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER PROVIDED REFERENCE RANGE: 0.70 TO 1.48 NG/DL): SID (B)(6) (FEMALE, 39-YEAR-OLD): INITIAL RESULT = 2.59 NG/DL, REPEATS = 1.02 NG/DL AND 1.06 NG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I FREE T4 RESULT FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER PROVIDED REFERENCE RANGE: 0.70 TO 1.48 NG/DL): SID (B)(6) (FEMALE, 39-YEAR-OLD): INITIAL RESULT = 2.59 NG/DL, REPEATS = 1.02 NG/DL AND 1.06 NG/DL NO IMPACT TO PATIENT MANAGEMENT WAS 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 THE REAGENT LOT. HOWEVER, TESTING WAS PERFORMED UTILIZING A RETAINED KIT OF LOT 73465UD00, WHICH CONTAINS THE SAME BULK MATERIAL AS LOT NUMBER 73465UD01, 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 REAGENT LOT AND COMPLAINT ISSUE. MANUFACTURING DOCUMENTATION FOR THE REAGENT 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 73465UD01, WAS IDENTIFIED.