FDA-Device2025-02-26Class II

Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001

Dexcom, Inc.

Hazard

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.

Sold states

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.

Affected count

N/A

Manufactured in

6340 Sequence Dr, N/A, San Diego, CA, United States

Products

Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1202-2025

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