Medtronic MiniMed, Inc. – FDA EIR, Jul 22, 2016

An FDA inspection of Medtronic MiniMed Inc., located in Northridge, CA, took place from July 5 to July 22, 2016. This high-priority inspection was a directed Investigational Device Exemption (IDE) review, focusing on a study for the Enlite 3 glucose sensor and associated transmitters, conducted under the regulatory guidance of 21 CFR Part 812. The main issue identified during the inspection, leading to a single observation on Form FDA-483, was inaccurate and incomplete records regarding device disposition. Specifically, investigational GST4C transmitters with an older software version (1.0A) were inadvertently used at clinical site 004 for three subjects, despite the study protocol requiring a newer software version (1.1A). Medtronic MiniMed did not detect this discrepancy during the clinical trial or prior to submitting the clinical data to the FDA, only discovering it on July 7, 2016, during the inspection. Although an internal impact assessment concluded that the software difference did not affect sensor data, the firm's failure to maintain accurate device accountability constituted a violation of 21 CFR 812.140(b)(2). Medtronic MiniMed management acknowledged the finding and committed to submitting a written response outlining their corrective actions to the Los Angeles District Office within 15 working days.