Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001
This recall is currently active, issued February 20, 2025. It was issued by Dexcom Inc.
- Company
- Dexcom Inc
- Recall Initiated
- January 27, 2025
- Posted
- February 20, 2025
- Recall Number
- Z-1203-2025
- Firm Location
- San Diego, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different conditions. First, if a receiver operating system .net error occurs when an alarm/alert should be triggered, the initial alarm/alert will not be delivered until a subsequent alarm/alert is triggered. At that time, the initial alarm/alert is delivered, but not the second one. Alarm/alerts will continue to be delayed and be one alarm/alert behind, causing delayed alarm/alerts until the receiver is reset. This condition could result in the missed detection of a hyperglycemic or hypoglycemic event. Second, a single EGV reading may be delayed for 5 minutes after the initial .net operating system error. If the user receives a single EGV reading delayed by 5 minutes, the delay is not expected to cause user harm.
Distribution
Worldwide - US Nationwide distribution in the states of OH, TX, PA, MN, SC, NH, FL, CA, NJ, PR, GA and the countries of Austria, Belgium, Canada, Switzerland, Germany, Spain, France, Ireland, Japan, Netherlands, Slovenia, United Kingdom, Australia, Czech Republic, Denmark, Finland, France, Hong Kong, Israel, Italy, Korea, Kuwait, New Zealand, Norway, Oman, Poland, Qatar, Saudi Arabia, Singapore, Slovakia, South Africa, Sweden, Turkey, United Arab Emirates.
Lot / Code Info
All Serial Numbers/UDI: 00386270000590
Root Cause
Software design
Action Taken
On January 27, 2025, Dexcom issued a "Urgent: Medical Device Correction to affected consignees via E-Mail. Dexcom asked consignees to take the following actions: If available, use the G6 App as primary display device to receive glucose readings and alerts. The G6 transmitter allows simultaneous communication with an iOS or Android device as well as a receiver (see letter for additional details). If using an affected G6 Receiver, check CGM glucose values and glucose trend regularly as CGM glucose values and glucose trend graph information continue to be displayed If you believe you may be experiencing the missed or delayed alarm/alerts issue, the issue can be corrected by shutting down the receiver and then turning it back on. Please navigate to the following webpage: https://www.dexcom.com/g6-receiver-update Please read the information provided on the webpage and any recommended actions regarding a software update for your receiver to permanently resolve this issue.