Beta Bionics, Inc. is recalling 1,080 units of the iLet Bionic Pancreas (model BB1001) due to a software issue involving versions 1.4.2 and 1.4.3. When used with a Dexcom G7 Continuous Glucose Monitoring (CGM) sensor, a software error can cause delayed readings that force the pump to switch to non-CGM dosing. In this mode, the pump only provides basic insulin doses and meal doses, failing to provide necessary correction doses or reduce/suspend insulin during high or low blood sugar events unless the user manually enters a blood glucose value.
This software failure can lead to severe high blood sugar (hyperglycemia), which may cause diabetic ketoacidosis (DKA), or severe low blood sugar (hypoglycemia) because the system stops automatically adjusting insulin based on real-time sensor data.
Software versions 1.4.3, and 1.4.2
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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