ACCU-CHEK ® INSTANT TEST STRIPS

Additional Manufacturer Narrative

THIS CASE, WITH PATIENT IDENTIFIER (B)(6) (SYSTEM 2), IS RELATED TO CASE WITH PATIENT IDENTIFIER (B)(6) (SYSTEM 1). THE EVENT OCCURRED OUTSIDE OF THE UNITED STATES. WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.

Description of Event or Problem

IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 9.4 MMOL/L WITH THE INSTANT SYSTEM (SYSTEM 1) AND 4.8 MMOL/L WITH THE GUIDE SYSTEM (SYSTEM 2) .