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U.S. Department of Health and Human Services

Class 2 Device Recall Dexcom G6 CGM App for iOS

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  Class 2 Device Recall Dexcom G6 CGM App for iOS see related information
Date Initiated by Firm November 19, 2019
Create Date March 02, 2020
Recall Status1 Terminated 3 on August 22, 2023
Recall Number Z-1104-2020
Recall Event ID 84436
510(K)Number K191450  
Product Classification Integrated Continuous Glucose Monitoring system, factory calibrated - Product Code QBJ
Product 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
Code Information Software Number: SW11677 Software Version: 1.4.0 up to corrected Version 1.4.4 GUDID Registered GTIN: 00386270000804
Recalling Firm/
Manufacturer
Dexcom Inc
6340 Sequence Dr
San Diego CA 92121-4356
For Additional Information Contact Anita Rees
858-875-9463
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
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 iOS App from the Apple App Store. Failure to update your App may cause your alarms and alerts to not work as intended. Without alarms/alerts, you might miss a severe low or high glucose event. Contact technical support if you require assistance. Duration: Day 4-17 Date Range: Nov 22 - Dec 5 App Compatibility Message: Warning - This version of the Dexcom G6 iOS App will no longer be available for use as of December 6. Update the Dexcom G6 iOS App now from the Apple App Store to continue use of the Dexcom G6 iOS App. Contact technical support if you require assistance. Duration: Day 18 Date Range: Dec 6 App Compatibility Message: Warning - This version of the Dexcom G6 iOS App is no longer available for use. Update the Dexcom G6 iOS App now from the Apple App Store to continue use of the Dexcom G6 iOS App. Contact technical support if you require assistance. For impacted users, they will receive the Alert Settings Reset notification once the app update is complete and the app is launched or the app receives a communication from the Transmitter. The user must then reset any alarm/alert customizations made (or leave at factory default settings). For users currently not impacted, they will not receive the Alert Settings Reset notification. The updated version of the app corrects the problem for those impacted and prevents the problem from occurring for
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = QBJ and Original Applicant = Dexcom, Inc.
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