Glucose monitoring app recalled because it can terminate and miss alerts
Dexcom is recalling version 1.15.0 of the G6 and G6 Pro Android CGM app because a software defect can terminate the app, stopping glucose values, alarms and alerts. The FDA classified it Class I.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the top severity regardless of other factors.
Plain-English summary
The Dexcom G6 and G6 Pro Android US CGM App, model SW11678, software version 1.15.0, a component of the Dexcom G6 Continuous Glucose Monitoring System, is being recalled.
A software defect in version 1.15.0 can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glucose values, alarms, alerts or notifications. Dexcom states this could result in the missed detection of a hyperglycemic or hypoglycemic event, potentially resulting in severe hyperglycemia, diabetic ketoacidosis (DKA), or hyperosmolar hyperglycemic state (HHS).
The recall covers 333 units carrying UDI 00386270000811 and was distributed throughout the United States. The FDA has classified the recall as Class I, its most serious category, used where there is a reasonable probability of serious injury or death.
People using the G6 Android app should check their app version and follow Dexcom's instructions.
The recalled product
- Product
- Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: SW11678 Software Version: version 1.15.0 Product Description: Dexcom G6 and G6 Pro Android US CGM App SW11678 version 1.15.0 Component…
- Manufacturer
- Dexcom, Inc.
- Affected units
- 333
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: UDI: SW11678 - 00386270000811
Distribution
Distribution scope not specified by the agency.
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