The manufacturer of the Omnipod 5 insulin delivery system is warning customers that its controller device does not register the decimal point in all cases, which could lead to the administration of dangerous doses.
Insulet said it had received two reports of “adverse events” directly related to the issue, but did not specify what they were. The company has written to customers stressing that administering the wrong dose can cause “severe hypoglycemia.” The company is developing a fix, but it is not yet available.
The issue is due to the way the controller’s bolus calculator (the tool that determines the correct insulin dose to take with meals) handles decimal places.
For example, if a user eats a meal containing 30 grams of carbohydrates, the app will determine how much insulin should be administered at the same time based on a real-time reading of the user’s current blood sugar level.
In the example outlined in Insulet’s field safety emergency notice, if you eat a meal containing 30g of carbohydrates and your current blood sugar level is 6.7 mmol/L, you would require an additional 0.3 units of insulin.
If the user enters a value of 0.3 in another way like .3
or .30
– Any value without a zero before the decimal point – The device ignores the first decimal point and issues a dose of 3 or 30 units, respectively.
Insulet cautioned users to always check the bolus amount before checking the dose, and said the device is still safe to use. Users can cancel the dose during administration if they discover errors in time.
The company said: “We are working diligently to fix this issue and look forward to a software update as soon as possible.” “We’ll notify you via email and update our website. Updates will be pushed to your device when they’re available. This update won’t cause you to lose any settings or history.”
Omnipod 5 is available in the UK, Germany and the US. Affected devices vary depending on the user’s geographic location.
Diabetics in the UK and Germany are controlling their Omnipod 5 doses using the Omnipod 5 Controller, a specialized device that includes the necessary software to remotely control insulin administration.
US-based users can access the same application as an Android app, subject to US-specific field safety notices. Posted All versions of the Android app are affected, with customers complaining about this issue. In Europe, only the current version of the standalone His Omnipod 5 controller (1.2.0) is affected.
According to multiple reports, this issue does not affect all users, and some users appear to be able to reproduce the issue only by: specific steps.
Customers in the Omnipod Reddit community report a variety of experiences. Going back three months, some people say the app sometimes removes leading zeros when manually entering values into the bolus calculator.
Others have stated that they are unable to reproduce the problem at all, where any attempt to enter a decimal point fails until they first enter a zero.
“Unfortunately, when developing software and services, we often focus on testing legitimate use cases to ensure that the functionality works correctly,” says Application Security at Featurespace. Director Sean Wright said. register.
“However, many people forget to test various scenarios where the system is not behaving properly, such as entering invalid data into the system. Neglecting these test cases can lead to disaster from security vulnerabilities. This can have serious and negative consequences.”
“Although it is unlikely that every possible scenario can be covered, it is important that the development team considers as many scenarios as possible and incorporates them into a large number of tests.”
According to an earnings call earlier this year, Insulet CEO Jim Hollingshead said Omnipod 5 has more than 100,000 customers out of the company’s total customer base of about 360,000. He said there was.
Recent press materials also stated that following the initial European launches this summer (the UK in June and Germany in August), Insulet plans to roll out Omnipod 5 to more European countries starting in 2024. I am.
A spokesperson for Insulet said: register: “Your health and safety is our top priority. That’s why Insulet is implementing a voluntary medical device modification for the Omnipod 5 app on compatible Android smartphones in the U.S. and the Omnipod 5 controller in the U.K. and Germany. Published.Related to bolus calculator.
“We have notified all affected users of the affected apps and devices and explained how they can avoid the risk of errors associated with bolus administration. Users can continue to use the Omnipod 5 automated insulin delivery system. It is safe to do so.” ®