| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00061-1 |
| Product Name/Description |
Medtronic Minimed 640G Infusion Pump used in clinical trials
Model Numbers: MMT-1511 & MMT-1512 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/01/2015 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic has implemented an amendment to the Pump User Guide for Medtronic MiniMed 640G Insulin Pumps. The change involves the bolus delivery accuracy listed in the Pump User Guide for very small bolus amounts (less than 0.1 U). Delivery accuracy for bolus volumes < 0.1 unit is now updated to ±20%, from ±5%. The delivery accuracy for bolus volumes = 0.1 unit remains ±5%, as does the delivery accuracy for basal delivery.
Medtronic considers that there is not likely to be any clinical risk associated with this change in delivery accuracy. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
An update to the published Instructions for Use (IFU) regarding the stated resolution of the device at a dose of <0.1 Unit is to be circulated to customers. This action has been closed-out on 08/08/2016. |
| Contact Information |
02 9857 9000 - Medtronic Regulatory Affairs |