ALINITY I INSULIN REAGENT KIT

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 HAS BEEN INCLUDED. NO ADDITIONAL PATIENT DETAILS ARE AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 04T75 HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 04T75, WHICH IS 510K EXEMPT.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I INSULIN RESULT GENERATED BY THE ALINITY I PROCESSING MODULE FOR A 4-YEAR-OLD MALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: REFERENCE RANGE: 2 TO 25 U/ML SID (B)(6): (B)(6) 2026 RESULT = 1.7 U/ML (B)(6) 2026 RESULT = 5.0 U/ML (B)(6) 2026 RESULT = < 1.6 U/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.