Medtronic MiniMed, Inc. – FDA EIR, Mar 14, 2018

An FDA inspection of Medtronic MiniMed, Inc. in Northridge, CA, was conducted from February 14 to March 14, 2018. The inspection focused on postmarket activities for the MiniMed 670G Pump and Guardian Sensor (3), operating under regulatory frameworks for medical device manufacturers and PMA postmarket inspections (Compliance Programs 7383.001 and 7382.845). The review covered design controls, corrective and preventive actions (CAPA), and production and process controls.

Two significant issues were identified and documented on an FDA-483. First, Medtronic MiniMed failed to submit 4,458 Medical Device Reports (MDRs) within the required 30-day period in 2017 for device malfunctions likely to cause or contribute to death or serious injury if they recurred (21 CFR 803.50(a)(2)). Second, the company did not adequately review, evaluate, or investigate complaints, particularly those leading to MDRs involving serious adverse events or injuries related to the MiniMed 670G Pump, failing to prioritize these critical investigations in a timely manner (21 CFR 820.198(c)).

Company management agreed with both observations, promising corrective measures. They committed to submitting a written response within 15 business days and discussed improvements to CAPA timelines, non-conformity investigation documentation, and trend analysis.