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Dexcom G6 recallZ-1104-2020 · Dexcom Inc · initiated Nov 19, 2019

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Dexcom Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Software design

What the company is doing

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

Recall details

Recall number
Z-1104-2020
Status
Terminated
Initiated by the company
Nov 19, 2019
Recalling firm
Dexcom Inc
Quantity
237888 users registered.
Product code
QBJ
FDA submissions
K191450
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.

Product description

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 (models, lots, serial numbers)

Software Number: SW11677 Software Version: 1.4.0 up to corrected Version 1.4.4 GUDID Registered GTIN: 00386270000804

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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