FDA EIR - Medtronic MiniMed, Inc. - February 15, 2019

The FDA conducted a for-cause inspection of Medtronic MiniMed, Inc. in Northridge, CA, from February 12-15, 2019, primarily to follow up on complaints regarding their Class II and III insulin infusion pumps and associated glucose sensors. The inspection was conducted under the regulatory framework for For-Cause Inspection of Medical Device Manufacturers.Key issues reviewed included a software defect in Model 670 insulin pumps (version 4.10) causing a loss of audible alarms if the ambient light sensor malfunctioned. Medtronic had initiated a voluntary field notification/recall (Z-0583-2019) to inform patients and offer replacements, while confirming pumps continued to vibrate and deliver insulin. The company anticipated a Class 2 recall classification. The inspection also addressed complaints of false readings from specific lots of Enlight sensors (Model MMT-7008), where no significant trend was identified.Further, the FDA investigator reviewed Medtronic's ongoing corrective and preventive actions (CAPAs) related to a previous recall (Z-2602-2605-2017) concerning "stuck button" alarms in Model 630 and 670G pumps, attributing the issue to inadequate design and testing. An isolated human error leading to a shipping anomaly was also identified and rectified. The inspection also covered an increase in manufacturing rejects for a "logarithmic failure" at Medtronic's Puerto Rico facility, with an internal investigation indicating no immediate patient safety risk as failures were detected during manufacturing, and remediation efforts were underway.At the conclusion of the inspection, the FDA investigator reported observing no new objectionable conditions that would require issuing an FDA Form 483, acknowledging Medtronic's active engagement in addressing these various product and process-related concerns.