ACCU-CHEK ® INSTANT TEST STRIPS

Additional Manufacturer Narrative

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 THIS CASE, WITH PATIENT IDENTIFIER CN-494772A, IS RELATED TO CASE WITH PATIENT IDENTIFIER CN-(B)(4).

Description of Event or Problem

IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 3.1 MMOL/L (AVIVA) AND 7.6 MMOL/L (INSTANT).