Insulet, a Massachusetts-based devicemaker that specializes in insulin pumps, sent users an "urgent" medical device correction Feb. 13, warning that a glitch in its software can lead to inaccurate doses of insulin.
Insulet said the devices are safe to use and distribute, as long as users follow steps detailed in the notice.
The software glitch in the Omnipod Dash devices can lead to the device giving a dose of insulin based on blood glucose readings more than 10 minutes old, which could be the incorrect dose. Improper doses of insulin could lead to hyperglycemia or hypoglycemia in users, the company warned.
Insulet said it has received 11 complaints about the issue but no reports of injuries.
Insulet said it plans to have replacement devices available in March once it fixes and tests its software. It plans to give the replacement devices to all affected users.
The notice came a day after Medtronic recalled 322,005 of its insulin pumps due to a hardware issue that caused the devices to give out improper insulin doses. That issue caused 2,175 injuries and one death.
Analysts at Stifel told Medtech Dive: "Issues like these are likely to continue for all current and future insulin pump manufacturers and underscores, again, that more work needs to be done to make pumps attractive and reliable."
Read the full news release here.