FDA 483 - Medtronic MiniMed, Inc. - July 22, 2016

Medtronic MiniMed Inc. in Northridge, CA, was inspected from July 5-22, 2016, revealing issues with device accountability. Specifically, records for the disposition of GST4C transmitters were not accurate or complete, leading to the use of incorrect software versions in a clinical study. This discrepancy was not identified until after clinical data was submitted to the FDA for IDE and PMA review.