Tandem Diabetes Care issued an urgent medical device correction to upgrade the software of its Tandem Mobi insulin pumps that can fail to deliver critical medicine to patients.
The software correction is for insulin pumps with the software versions of 7.6.0.1, 7.6.0.3, and 7.7.0.1, the company said in a a recall notice posted to the FDA website. The correction was first issued by Tandem in early October but was published by the FDA only last week.
The software update to correct the issue with the devices is called version 7.9.0.2, and prevents a “malfunction 12” that can prevent insulin delivery and cut communication between the insulin pump and the continuous glucose monitoring (CGM) device, as well as the Tandem Mobi mobile app.
A failure could result in hyperglycemia because of the lack of insulin. Sever cases of hyperglycemia can result in hospitalization or intervention from a medical professional.
As of early November, the company had received four reports of serious injuries related to the software problem, but no deaths.
The FDA has now classified the recall as Class I, the most serious type. More than 17,700 devices have been affected.
The devices a battery-operated infusion pumps capable of both basal and bolus delivery of insulin. A motor-driven mechanism delivers insulin from a disposable cartridge, through an infusion set, into a patient’s subcutaneous tissue.
The software patch can be accessed remotely from within the Tandem Mobi Mobile app or contact the company at 1-877-801-6901 or [email protected].
