Beta Bionics, Inc.: Alternate Controller Enabled Insulin Infusion Pump
Updated 3 hours ago ()
insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch to non-CGM dosing, leading to only basal/requested meal doses provided, no correction doses/insulin reductions/suspensions for high/low glucose unless blood glucose entered for sensor life or replacement. Potential health risks to users include severe hyperglycemia with and without DKA and severe hypoglycemia.
- Tags
- FDA recall, medical device, class 2, Clinical Chemistry, Software change control, Open, Classified
- Related exam domains
- CISSP 3: Security Architecture and Engineering; CISSP 4: Communication and Network Security; CISSP 7: Security Operations; CISM 3: Information Security Program
- Source record id
- Z-1996-2026
- First seen by InfoSec Signals
- Sep 23, 2026
Source: openFDA device recalls, U.S. Food and Drug Administration about this source more from it
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