麻豆传媒

A shorter-than-expected battery life prompted a voluntary recall of certain insulin pumps from Medtronic's MiniMed 600 and 700 series, the on Thursday.

Affecting all lots, serial numbers, and of the MiniMed 630G, 670G, 770G, and 780G products, the portable pumps have an increased risk for reduced battery life and a shorter time until shutdown after a battery alert occurs.

"Pumps that have been dropped, bumped, or experienced another physical impact may have damaged electrical components causing this issue -- even a single drop can impact battery life," the FDA noted. "This may result in the pump stopping insulin delivery significantly sooner than usually expected."

this battery issue could happen either immediately after a drop or over time and that the issue will continue even after replacing the battery.

"This electrical issue also causes battery alerts to occur when less battery life remains than the User Guide states," the maker noted.

While the pump will still generate battery alerts and alarms, they may not be delivered with the usual amount of battery life remaining before the battery must be replaced to avoid the pump stopping insulin delivery, the company said.

This was classified as a class I recall -- the most serious type -- since using the affected product could cause serious adverse health consequences like hyperglycemia, diabetic ketoacidosis, or death.

There have been 170 reports of hyperglycemia (blood glucose over 400 mg/dL) and 11 reports of diabetic ketoacidosis potentially related to the battery issue between January 2023 through last month. So far, no deaths have been reported.

The ongoing issue first came to light in July when Medtronic sent all impacted customers detailing the following built-in battery alerts:

• The "low battery pump" alert will display when your pump has up to 10 hours of battery life left.
• The "replace battery" alert will display when the pump has less than 30 minutes of battery life left.
• If the battery is not replaced within 10 minutes, a siren will sound and repeat once every minute until the "replace battery now" alarm is displayed. At that time, the pump will stop insulin delivery.

Users should be prepared to replace the battery as soon as the "low battery pump" alert sounds. Because of this, users should always carry an extra set of new AA lithium, alkaline, or fully charged NiMH batteries in case a battery change is needed sooner than expected.

All users should also carry back-up insulin therapy at all times in case of an emergency.

This recall does not involve removing all products. If users experience significantly reduced battery life, they should contact Medtronic to determine if a new pump is needed regardless of whether the pump has been dropped, bumped, or experienced physical impact.

Comment