ALINITY I FREE T4 REAGENT KIT

Additional Manufacturer Narrative

COMPLETE INFORMATION FOR SECTION A PATIENT INFORMATION, 1. PATIENT IDENTIFIER = SID= (B)(6). 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.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY DECREASED THYROID TESTS RESULTS GENERATED FROM ALINITY I PROCESSING MODULE FOR A 30 DAY OLD NEWBORN MALE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2025, SID (B)(6), FREE T4 INITIAL= 0.69 NG/DL (REFERENCE RANGE=0.89 TO 1.7 NG/DL) AFTER HOSPITALIZATION EXAMINATIONS DUE TO CONTINUOUS JAUNDICE AND FEVER, THE PATIENT UNDERWENT THYROID FUNCTION TESTING ON (B)(6) 2025 USING A SIEMENS PLATFORM. THE RESULTS PROVIDED WERE: FREE T4= 1.25 NG/DL (REFERENCE RANGE=1.02 TO 1.71 NG/DL) THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, DEVICE HISTORY RECORD REVIEW, AND LABELING REVIEW, IN-HOUSE TESTING WAS PERFORMED FOR ALINITY I FREE T4 REAGENT LOT 73465UD01. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT 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 73465UD01. HOWEVER, TESTING WAS PERFORMED UTILIZING RETAINED KIT AND NOTED THAT ALL TESTING PASSED, INDICATING THE REAGENT LOT IS PERFORMING AS EXPECTED. THE DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH LOT NUMBER 73465UD01 AND THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I FREE T4 FOR LOT 73465UD01 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY DECREASED THYROID TESTS RESULTS GENERATED FROM ALINITY I PROCESSING MODULE FOR A 30DAY OLD NEWBORN MALE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2025 SID (B)(6) FREE T4 INITIAL= 0.69 NG/DL (REFERENCE RANGE=0.89 TO 1.7 NG/DL) AFTER HOSPITALIZATION EXAMINATIONS DUE TO CONTINUOUS JAUNDICE AND FEVER, THE PATIENT UNDERWENT THYROID FUNCTION TESTING ON JULY ON 19JUL2025 USING A SIEMENS PLATFORM. THE RESULTS PROVIDED WERE: FREE T4= 1.25 NG/DL (REFERENCE RANGE=1.02 TO 1.71 NG/DL). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.