The U.S. Food and Drug Administration (FDA) says at least 224 people with diabetes have reported injuries linked to a faulty app iOS that caused their insulin pumps to shut down prematurely.
On Wednesday, the agency announced that medical device manufacturer Tandem Diabetes Care has issued a recall for version 2.7 of its iOS t:connect mobile app , which is used in conjunction with the company’s t:slim X2 insulin pump . The company decided to issue the recall because of a software issue that can cause the app to repeatedly crash and restart, resulting in the pump’s battery draining due to excessive Bluetooth connections .
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As users have reported, the battery is running low, causing the insulin pump to shut down “earlier than expected.” However, there is a notification of impending shutdown via an alarm and low-power notification. The company is urging customers to update the app to version 2.7.1 or later to fix the software issue.
Although we're not talking about a physical recall, the FDA has recognized this as a "Class I" recall, which is the most serious type of recall. This is because it's an issue that can cause serious problems or even death.
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Discontinuing the pump will cause insulin delivery to be suspended, which could lead to underproduction of insulin. This in turn leads to elevated blood, known as hyperglycemia, which are dangerous if not treated immediately.
“In severe cases of hyperglycemia, due to a prolonged period of non-administration of insulin, the user may experience diabetic ketoacidosis and may require hospitalization or intervention by a physician.
Finally, the uncertainty and anxiety caused by the insecurity of insulin pump operation can have significant impacts on patients' mental health
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Fortunately, no deaths have been reported due to this app issue. Tandem encourages users to be especially careful when sleeping, as they may not notice low battery.
Source: www.theverge.com
