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

Medtronic MiniMed Inc., a medical device manufacturer and clinical research sponsor based in Northridge, CA, underwent an FDA inspection from July 5 to July 22, 2016. This inspection resulted in the issuance of a Form FDA 483, an official report of observations, pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act. The primary observation centered on the firm's inadequate control and documentation of devices used in clinical studies. Specifically, records for the disposition of devices, including batch numbers and reasons for disposition, were found to be inaccurate and incomplete. During a performance evaluation study for the Enlite 3 Sensor, Medtronic MiniMed failed to fully retrieve GST4C transmitters with an initial software version from clinical sites before enrolling subjects for a study intended to use an updated software version. This led to certain subjects at one site using devices with the unapproved initial software. Although a subsequent internal assessment indicated no difference in sensor data due to the software version, this discrepancy was not identified during the clinical trial or prior to the submission of clinical data to the FDA. These findings require Medtronic MiniMed Inc. to address the observations and implement corrective actions to ensure rigorous device accountability and complete record-keeping for clinical investigations.