Recent FDA announcements deal with insulin pumps
The agency announced a recall of a series of Medtronic insulin pumps and offered information about preventing damage to pumps and monitors during CT scans and X-rays.
The FDA made two announcements relevant to diabetes care in October.
On Oct. 17, the FDA announced a class I recall of Medtronic's MiniMed 600 and 700 series insulin pumps due to an increased risk for reduced battery life and less time until shutdown after a battery alert. Pumps that have been dropped or bumped or have experienced another physical impact may have damaged electrical components causing this issue—even one drop can impact battery life. From January 2023 to September 2024, Medtronic received 170 reports of hyperglycemia and 11 reports of diabetic ketoacidosis related to this issue.
The agency also recently released new information on how to prevent damage to wearable diabetes devices from CT scans, X-rays, and radiation therapy. The FDA guidance, updated Oct. 15, says that a wearable diabetes device should not prevent receipt of appropriate, medically indicated procedures. With the exception of high-strength radiation therapy, procedures pose an extremely low risk of a device problem, the agency said. It noted that the manufacturers of insulin pumps and continuous glucose monitors typically recommend removing the device and leaving it outside of the room before diagnostic X-ray imaging or radiation therapy.