—#182620

Product

The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.

FDA product code: MDS — Sensor, Glucose, Invasive
Device class: Class 3
Medical specialty: Unknown
Affected lot / code info: Product Number - CSS7200 UDI (GTIN.UPN) - 00763000255404

Why it was recalled

As a result of the release of new software version to CareLink Personal website, the IOS app for the Continuous Monitoring Glucose system stopped automatically uploading data to the website.

Root cause (FDA determination)

Software design

Action the firm took

On July 15, 2020, the firm sent an "URGENT FIELD SAFETY NOTIFICATION" to customers/Care Partners/Healthcare Professionals via email informing them that the Recalling Firm released an update to the CareLink Personal Software. Following the release of the software, several customer using the iOS app experienced data connectivity disruptions and as a result: 1. Care partners may not receive SMS alerts 2. Care partners remote access monitoring in the CareLink Connect web app may show data gaps 3. Customers may see data gaps in their reports. Customer are instructed to: 1. Attempt to manually upload your data to the CareLink" software via the Guardian" Connect app: a. Tap on the top left corner of the Home Screen b. Confirm Sync to CareLink is enabled c. Tap Upload Now d. Wait 10 minutes before moving to step #2. 2. Check your account to see if you are experiencing this issue a. From your mobile device visit https://carelink.minimed.eu and log in to your CareLink" account b. Confirm that your data is visible in the CareLink" Connect web app c. If your data is visible, no further action is needed - you are not experiencing the issue d. If your data is not visible, you may be experiencing the issue and you should complete the steps in the next section to resolve the issue. Instructions for Resolving the Issue (refer to the Frequently Asked Questions included for detailed instructions) 1. If your data was not visible after step #2, uninstall the Guardian" Connect app from your mobile device. For help, please refer to FAQ below #3 2. Unpair your transmitter from your mobile device. For help, please refer to FAQ below #3 3. Re-install the Guardian" Connect app on your mobile device this will restore the CareLink" connection. For help, please refer to FAQ below #4 *Uninstalling the Guardian" Connect app may delete visible data from the app. All data that has been uploaded to the CareLink" software will continue to be visible in CareLink" report

Recalling firm

Firm: Medtronic Inc.
Address: 18000 Devonshire St, Northridge, California 91325-1219

Distribution

Distribution pattern: International distribution including in the countries of EMEA - Austria, Belgium, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Kuwait, Latvia, Luxembourg, The Netherlands, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Arab Emirates, and United Kingdom. Latin America- Chile, Colombia and Mexico Asia Pacific (APAC) - Australia, India, Japan, The Republic of Korea, Malaysia, New Zealand, Russia Federation, Singapore, Thailand, and Vietnam. Asia - Hong Kong North America - Canada

Timeline

Recall initiated: 2020-07-15
Terminated: 2022-02-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #182620. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.