Update: As stated by Insulet, Omnipod, ‘Your Omnipod 5 Controller software will be updated on December 14, 2023, with version 1.2.4. The software update will fix the issue discussed in the recent Field Safety Notification (REF: 9056196-11/22/2023-001-C) pertaining to the bolus calculator.’

Insulet, the manufacturer of the Omnipod 5 insulin-delivery system, has warned its customers about an issue with its controller device failing to register decimal points consistently.

The glitch could lead to incorrect doses and pose risks to users.

Insulet highlighted two adverse events directly associated with this problem, like severe hypoglycaemia.

Insulet has communicated this concern to its customers and is actively working on a solution although it is not yet available.

What is the issue?

The problem is with how the bolus calculator handles decimal points.

This calculator helps in determining the precise insulin dosage required for a meal, checking the user’s real-time glucose levels.

In a scenario outlined by Insulet’s safety notification, a 30-gram carbohydrate meal with a glucose level of 6.7 mmol/L would need an additional 0.3 units of insulin.

However, if the user inputs the value, such as .3 or .30, without a zero before the decimal point, the device ignores the initial decimal point.

Therefore, it administers a dose equivalent to either 3 or 30 units.

Please remember: double-check the bolus amount before confirming the dosage and assured that the device remains safe for use.

Users can cancel dosages mid-administration if they detect an error in time.

“We are diligently addressing this issue and anticipate a software update soon,” stated an Insulet representative.

“We will notify you via email and update our website. Once available, the update will be automatically pushed to your device, without affecting your settings or history.”

Does this affect all Omnipod 5 users?

The Omnipod 5 is available in the UK, Germany, and the USA with affected devices based on the user’s geographic location.

In the UK and Germany, customers regulate the Omnipod 5 dosage using the Omnipod 5 Controller device.

The company’s US-specific safety notice confirms that all versions of the Android app are impacted.

Only the current version of the standalone Omnipod 5 Controller (1.2.0) is affected in Europe.

While reports indicate that the issue does not affect some users, some can recreate it by following specific steps.

The problem is inconsistent, with some users experiencing difficulties entering a decimal point without typing a zero first.

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