Dexcom One Continuous Glucose Monitoring System Receiver Speaker Defect
Dexcom, Inc. is recalling Dexcom One Continuous Glucose Monitoring System receivers due to potential defective foam or assembly errors that may cause the speaker to lose contact with internal components, resulting in missed audible alerts for dangerous blood glucose levels.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA classified this as a Class I recall. The source text explicitly states that the defect could lead to death, which is a criterion for Critical severity per the rubric.
Plain-English summary
Dexcom, Inc. is recalling the Dexcom One Continuous Glucose Monitoring System due to a defect in the receiver device. The defect involves either defective foam or an assembly error that may cause the receiver speaker to lose contact with the printed circuit board.
As a result of this defect, users may not receive audible alerts when their blood glucose levels become dangerously low (hypoglycemia) or high (hyperglycemia). Missed alerts could prevent timely treatment of these conditions.
Untreated low or high blood glucose can cause serious medical complications, including seizures, vomiting, loss of consciousness, or death. The affected devices are distributed worldwide, including in the United States and in multiple countries across Europe, Asia, the Middle East, Africa, and Oceania.
Consumers who have a recalled Dexcom One receiver should contact Dexcom, Inc. for information about device replacement or corrective action. Patients should not rely solely on the receiver's audible alerts and should continue to monitor their blood glucose levels by other means.
The recalled product
- Product
- Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 (MT27409-1), STK-DO-013 (MT27409-1), STK-DO-103 (MT27409-2), STK-DO-109 (MT27409-2)
- Manufacturer
- Dexcom, Inc.
- Hazard
- speaker-malfunction
- missed-alerts
- hypoglycemia
- hyperglycemia
Distribution
Distributed nationwide across the United States.
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