ARCHITECT INSULIN

Additional Manufacturer Narrative

THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORTED THE COMPLAINT ISSUE. A REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT INSULIN ASSAY DID NOT IDENTIFY ANY TRENDS RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 84221LP01. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES, OR DEVIATIONS WITH THE COMPLAINT LOT AND THE COMPLAINT ISSUE. HISTORICAL PERFORMANCE OF THE ARCHITECT INSULIN REAGENT LOT 84221LP01 WAS REVIEWED USING FIELD DATA FROM CUSTOMERS WORLDWIDE. THE PATIENT¿S DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THE PATIENT MEDIAN RESULT FOR LOT 84221LP01 IS WITHIN THE ESTABLISHED CONTROL LIMITS; THEREFORE, NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED. 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 ARCHITECT INSULIN REAGENT, LOT NUMBER 84221LP01.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT INSULIN RESULT FOR A 35-YEAR-OLD MALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2026, SID (B)(6): INITIAL RESULT WAS >300 UU/ML, REPEAT WITH 1:2 AUTOMATIC DILUTION WAS >600 UU/ML. THE SAMPLE WAS SENT TO ANOTHER LABORATORY WHICH GENERATED A RESULT OF 13.20 UU/ML WITH ROCHE. 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. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. ALL AVAILABLE PATIENT INFORMATION WAS PROVIDED, NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT INSULIN RESULT FOR A 35 YEAR OLD MALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2026, SID (B)(6): INITIAL RESULT WAS >300 UU/ML, REPEAT WITH 1:2 AUTOMATIC DILUTION WAS >600 UU/ML THE SAMPLE WAS SENT TO ANOTHER LABORATORY WHICH GENERATED A RESULT OF 13.20 UU/ML WITH ROCHE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.