iLet Bionic Pancreas Software Versions Recalled for Delayed CGM Readings
Beta Bionics is recalling iLet Bionic Pancreas units with software versions 1.4.2 and 1.4.3 due to a compatibility issue with Dexcom G7 sensors that can cause delayed glucose readings and loss of automatic insulin adjustments.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves an FDA Class II device with identified potential for serious adverse health outcomes (severe hyperglycemia with DKA and severe hypoglycemia), which meets the Severe criterion even without reported cases of actual illness or injury.
Plain-English summary
Beta Bionics, Inc. is recalling the iLet Bionic Pancreas (REF: BB1001) with software versions 1.4.2 and 1.4.3 due to an issue affecting compatibility with Dexcom Continuous Glucose Monitoring (CGM) G7 sensors. The software malfunction may result in delayed CGM readings, after which the pump switches to non-CGM dosing mode.
When operating in non-CGM mode, the pump provides only basal insulin doses and user-requested meal doses. The device cannot deliver correction doses, insulin reductions, or suspensions in response to high or low blood glucose levels unless the user manually enters blood glucose readings. This limitation persists until either the end of the G7 sensor's life or sensor replacement.
The potential health risks associated with this issue include severe hyperglycemia with or without diabetic ketoacidosis (DKA) and severe hypoglycemia. Approximately 1,080 units have been distributed nationwide across Texas, Pennsylvania, Alabama, Michigan, Ohio, Florida, Tennessee, and Georgia.
The recalled product
- Product
- iLet Bionic Pancreas, REF: BB1001
- Manufacturer
- Beta Bionics, Inc.
- Hazard
- sensor-malfunction
- delayed-dosing
- hyperglycemia
- hypoglycemia
- dka
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Software versions 1.4.3
- and 1.4.2
Distribution
Distributed nationwide across the United States.