Recall Z-0776-2023 ยท MDS Sensor, Glucose, Invasive
Medtronic MiniMed
Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system
| Date | Jan 1, 2023 (initiated Nov 21, 2022) |
| Status | Open, Classified |
| Reason | An app, part of a continuous glucose monitoring system, for use with smartphone devices may automatically log out from CareLink, then the app is not able to upload data. When logged out, linked care partners will not receive SMS notifications (could result in hypoglycemia or hyperglycemia), and sensor glucose values will also not be sent to the InPen app. |
| Root cause | Software change control |
| Action | On 11/21/22, correction notices were sent to patients, care partners, and healthcare providers. The following actions were requested of users: iOS/Android Users: 1) Verify what version of the app you are running by taking the following steps: a) On the home screen, navigate to the settings menu on the upper left corner b) Select "Help" c) Confirm "Version" 2) If you are not running version 1.3.0, no action is necessary 3) If you have version 1.3.0, update to the latest app version currently available in the App Store (1.3.1) by following these steps: iOS Users: a) Open the App Store app. b) |
| Quantity | 3235 |
| Distribution | OUS: Austria, Belgium, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Kazakhstan, Kuwait, Luxembourg, Moldova, Republic of, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.