Dexcom ONE+ iOS CGM App Software Defect Delayed Glucose Alerts
Dexcom, Inc. is recalling Dexcom ONE+ iOS CGM App versions 1.5.0 and 1.6.0 due to a software defect that can delay glucose alerts and notifications, risking delayed detection of low or high blood sugar events.
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: This is an FDA Class II recall of a medical device with a software defect that creates a risk of harm to users (missed detection of dangerous blood sugar events and delayed treatment decisions). The source text explicitly states no illnesses or injuries have been reported, placing it at the upper end of High severity under the rubric's criterion for "risk-of-harm products where injury has not yet been reported."
Plain-English summary
Dexcom, Inc. is recalling the Dexcom ONE+ iOS CGM App (Model SW14244, versions 1.5.0 and 1.6.0) distributed internationally, including to the United Kingdom, Australia, New Zealand, Canada, and other countries listed in the recall notice.
The recalled app contains a software defect in which a low-priority file input/output (I/O) check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app runs in the background, glucose notifications may queue up and then replay sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous glucose readings. In more severe cases, the app may perceive signal loss and deploy signal loss mitigations.
This delay in glucose value and alert processing creates a risk that users may miss detection of hypoglycemic (low blood sugar) or hyperglycemic (high blood sugar) events, or make treatment decisions based on outdated glucose information.
Users of the affected app should check for and install any available software updates from Dexcom. For additional information or concerns, patients should contact their healthcare provider or Dexcom customer support.
The recalled product
- Product
- Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.5.0 and 1.6.0 Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring Syste
- Manufacturer
- Dexcom, Inc.
- Hazard
- software-defect
- delayed-alerts
- signal-loss
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 (1)
- Lot Code: SW14244 versions 1.5.0 and 1.6.0 - UDI-DI: 00386270004307
Distribution
Distributed nationwide across the United States.