Recall Z-1228-2015 ยท LZG Pump, Infusion, Insulin
Medtronic MiniMed Inc.
CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application designed to enhance Health Care Provider management of diabetic patients using Medtronic insulin pumps and blood glucose meters. MMT-7335 is intended for use by Health Care Providers/Physicians as a therapy management accessory to: - read and store history and settings data supported insulin pump models and s
| Date | Mar 2, 2015 (initiated Nov 10, 2014) |
| Status | Terminated |
| Reason | The firm is informing customers of a software error that might result in an inaccurate display of the Temp Basal time and duration in CareLink Clinical reports with data uploaded from the MiniMed 620G or 640G insulin pump. |
| Root cause | Software design |
| Action | Medtronic MiniMed Inc. sent an Urgent Medical Device Correction letter in December 2014 to all affected customers. The firm states in their letter that patients can continue to use their MiniMed 620G and 640G insulin pump systems, and that there is no risk to patients caused by this issue. The firm instructs that when reviewing the CareLink Pro 4.0 or CareLink Clinicial reports from the MiniMed 620G and 640G insulin pumps not to use the Temp Basal graphic for clinical consideration. For questions regarding this recall call 818-567-4700. |
| Quantity | 5 CareLink Pro 4.0 CD ROMs |
| Distribution | Worldwide Distribution to Japan only. CareLink Clinical is for clinical trials only (US and International) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.