Recall Z-1104-2020 ยท QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated
Dexcom Inc
Brand Name: Dexcom G6 CGM App for iOS Software Number: SW11677 Software Version: Version 1.4.0 up to corrected Version 1.4.4 GUDID Registered GTIN: 00386270000804
| Date | Nov 19, 2019 |
| Status | Terminated |
| Reason | It was reported that the user's low alarm feature on the iOS application were not properly alerting users when the user has enabled the Alert Schedule feature more than 30 days after installing the iOS application. |
| Root cause | Software design |
| Action | An updated G6 iOS CGM App was placed in the Apple App Store (SW11677 version 1.4.4) with messaging pushed to all US users on November 19, 2019. The messaging repeats to the user on a daily basis until the user updates (or is alternatively blocked from use of the app if they ignore the messaging and do not update). Messaging will be delivered directly to the end user through the following App Compatibility Messaging via the Apple App Store (see Compatibility Message and time-frame below): Duration: Day 1-3 Date Range: Nov 19-21 App Compatibility Message: Warning - Please update your Dexcom G6 |
| Quantity | 237888 users registered. |
| Distribution | US Nation-wide OUS: Austria; Belgium; Canada; Czechia; Denmark; Finland; Germany; Great Britain; Hong Kong; Ireland; Italy; Luxembourg; Netherlands; Norway; South Africa; Spain; Sweden, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191450 | Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexco Dexcom, Inc., Jun 28, 2019 |