ALINITY I FREE T4 REAGENT KIT

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I FREE T4 RESULT GENERATED BY THE ALINITY I AM PROCESSING MODULE FOR A PATIENT. THE RESULT WAS NOT RELEASED OUT OF THE LAB. THE SAMPLE WAS REPEATED, AND A LOWER RESULT WAS OBTAINED. THE FOLLOWING DATA WAS PROVIDED: SID: (B)(6): INITIAL RESULT = 47.5 PMOL/L (LOT#: 70400UD00); REPEAT RESULT = 18.52 PMOL/L (LOT#: 70400UD00). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

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 A FALSELY ELEVATED ALINITY I FREE T4 RESULT GENERATED BY THE ALINITY I PROCESSING MODULE FOR A PATIENT. THE RESULT WAS NOT RELEASED OUT OF THE LAB. THE SAMPLE WAS REPEATED, AND A LOWER RESULT WAS OBTAINED. THE FOLLOWING DATA WAS PROVIDED: SID: (B)(6): INITIAL RESULT = 47.5 PMOL/L (LOT#: 70400UD00); REPEAT RESULT = 18.52 PMOL/L (LOT#: 70400UD00) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, A SEARCH FOR SIMILAR COMPLAINTS, A TICKET TRENDING REVIEW, A DEVICE HISTORY RECORD REVIEW, A LABELING REVIEW, AND IN-HOUSE TESTING OF RETAINED REAGENT KIT. THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A SEARCH FOR SIMILAR COMPLAINTS IDENTIFIED AN INCREASE IN COMPLAINT ACTIVITY FOR LOT: 70400UD00. ADDITIONALLY, A REVIEW OF TRACKING AND TRENDING DATA FOR THE ALINITY I FREE T4 ASSAY IDENTIFIED AN INCREASE IN COMPLAINTS. HOWEVER, IN-HOUSE PERFORMANCE TESTING WAS PERFORMED UTILIZING RETAINED REAGENT KIT OF THE COMPLAINT LOT. ALL TESTING PASSED INDICATING THE REAGENT LOT IS PERFORMING AS EXPECTED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCE'S OR DEVIATIONS WITH LOT NUMBER: 70400UD00 AND THE COMPLAINT ISSUE. A REVIEW OF LABELING WAS PERFORMED AND FOUND TO SUFFICIENTLY ADDRESS THE CUSTOMER'S ISSUE. BASED ON THIS INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ALINITY I FREE T4 REAGENT, LOT NUMBER: 70400UD00.