iLet Ace insulin pump lock screens can be bypassed by users
iLet Ace Pump Kits are being recalled because active status bar icons on the lock and passcode screens allow those screens to be bypassed, permitting unauthorized access.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall where a lock screen can be bypassed and unauthorized changes made to insulin delivery, a risk of harm with no injuries reported in the source.
Plain-English summary
The iLet Ace Pump Kit, REF BB1001, with iLet Dosing Decision Software, is being recalled. The action covers 15 units running software version BOM000036 Rev C (version 1.4.2) or older.
In software versions 1.3.7, 1.4.2 and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interface include certain icons displayed in the status bar that are active. Pressing those icons allows the user to bypass those screens, permitting unauthorised access while the device is in Limited Access Mode. According to the manufacturer, an associated health risk includes severe hypoglycemia due to unauthorised access to the iLet. The FDA classified the action as Class II.
Distribution was nationwide in the United States across a large number of states. The pumps are supplied for patient insulin delivery.
Users and providers should identify affected devices by software version and follow the instructions issued by the manufacturer. Patients should not stop prescribed insulin therapy without medical advice.
The recalled product
- Product
- iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
- Manufacturer
- Beta Bionics, Inc.
- Category
- Medical Device — Insulin pump
- Hazard
- software-issue
- access-control-bypass
- hypoglycemia-risk
- class-ii
- insulin-delivery
Distribution
Distributed nationwide across the United States.
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