Recall Z-0843-2021 ยท MDS Sensor, Glucose, Invasive
Medtronic Inc.
CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software Tool for Diabetes Software Uploader versions: 3.1.5.000 3.1.2.000
| Date | Nov 12, 2020 |
| Status | Open, Classified |
| Reason | Incomplete basal rate information may be transmitted leading to a potential for inappropriate change in therapy. During data upload, radio frequency (RF) interference can occur at any point from surrounding devices or equipment that may affect the data transfer between the insulin pump and the CareLink Personal or CareLink System Software. |
| Root cause | Device Design |
| Action | On 11/19/2020, the firm sent an "URGENT FIELD SAFETY NOTIFICATION" Letter via email, fax, mail and/or phone to its U.S. Customer, and on 12/07/2020, the firm initiated O.U.S Notification using approved regional methods. The Notification Letter informs customers that after the release of an updated uploader software version the following issues/scenarios may result: 1. Some reports may be missing all programmed basal rates in the device. This may result in a blank value on the Device Settings report of the 24-hour basal total. 2. Some reports may only display certain programmed basal rates and |
| Quantity | 46,461 affected systems |
| Distribution | U.S. Nationwide O.U.S. Worldwide Refer to Associated Documents and uploaded Consignee Lists/Spreadsheets. -Australia New Zealand -Canada -EMEA -Greater China -India -Japan -Latin America -South Korea -Southeast Asia -US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151236 | MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal) Medtronic Minimed, Inc., May 19, 2015 |