ALINITY I FREE T4 REAGENT KIT

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 RESULTS GENERATED FOR A 5-YEAR-OLD PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED: INITIALLY MULTIPLE ASPIRATION/PIPETTOR ASPIRATION ERRORS, ERROR MESSAGE 3471 ¿ EXCEPTION, WAS OBSERVED. SAMPLE ID (B)(6), INITIAL RESULT ON (B)(6) 2025 = >64.4, SAME PATIENT, NEW SAMPLE WAS OBTAINED ON (B)(6) 2025 AND RESULTS = > 64.35, > 64.35, > 64.35. 3 DAYS LATER A NEW SAMPLE WAS OBTAINED. SAMPLE ID (B)(6) RESULT = 15.1. OTHER RESULTS PROVIDED THAT THE CUSTOMER IS NOT QUESTIONING: TSH SAMPLE ID (B)(6), INITIAL RESULT = 1.11, 3 DAYS LATER A NEW SAMPLE WAS OBTAINED. SAMPLE ID (B)(6) RESULT = 1.66. FT3 SAMPLE ID (B)(6) INITIAL RESULT = 7.8. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FINAL 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.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION OF LOT 73465UD00 INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND IN HOUSE TESTING OF A RETAINED REAGENT KIT LOT 73465UD00. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. 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 73465UD00. HOWEVER, TESTING WAS PERFORMED UTILIZING RETAINED KITS OF LOT 73465UD00 AND NOTED THAT ALL TESTING PASSED, INDICATING THE REAGENT LOTS ARE PERFORMING AS EXPECTED. THE TICKET SEARCH BY LOT INDICATES THAT THE REAGENT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. TICKET TRENDING REVIEW FOR THE LIST NUMBER DID NOT IDENTIFY ANY RELATED TRENDS. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I FREE T4 REAGENT LOT 73465UD00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 RESULTS GENERATED FOR A 5-YEAR-OLD PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED: INITIALLY MULTIPLE ASPIRATION/PIPETTOR ASPIRATION ERRORS, ERROR MESSAGE 3471 ¿ EXCEPTION, WAS OBSERVED. SAMPLE ID (B)(6), INITIAL RESULT ON (B)(6) 2025 = >64.4, SAME PATIENT, NEW SAMPLE WAS OBTAINED ON (B)(6) 2025 AND RESULTS = > 64.35, > 64.35, > 64.35. 3 DAYS LATER A NEW SAMPLE WAS OBTAINED. SAMPLE ID (B)(6) RESULT = 15.1. OTHER RESULTS PROVIDED THAT THE CUSTOMER IS NOT QUESTIONING: TSH SAMPLE ID (B)(6) INITIAL RESULT = 1.11, 3 DAYS LATER A NEW SAMPLE WAS OBTAINED. SAMPLE ID (B)(6) RESULT = 1.66, FT3 SAMPLE ID(B)(6), INITIAL RESULT = 7.8 . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.