| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00661-1 |
| Product Name/Description |
MiniMed 640G Insulin Infusion Pump
ARTG Number: 95763 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
2/06/2017 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic has identified an issue that may potentially affect the MiniMed 640G Insulin Infusion Pump. Keypad buttons on the MiniMed 640G series insulin pumps may become temporarily unresponsive when the atmospheric pressure around the pump increases or decreases rapidly. This would most likely happen when travelling in an airplane during take-off or landing.
During this temporary situation, a button may be too difficult to press down or a button can look like it is physically pressed down and stuck in that position. If patients notice the keypad buttons are difficult to press down, the pump will continue to deliver basal insulin. Patients may not be able to program a bolus or suspend delivery as the buttons temporarily will not press down, but this will resolve on its own, usually within 30 minutes. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Users are advised that If they experience this temporary keypad condition, and want to resolve it immediately to bolus or clear the alarm:
Remove the battery cap from the pump and then place it back on.
A fresh new AA battery should be available in the event the pump prompts users to insert a new battery.
In the short term an errata sheet will be provided with new devices until such time as this information can be permanently incorporated into the Instructions for Use (IFU).
This action has been closed out on the 22/11/2018. |
| Contact Information |
1800 777 808 - Medtronic 24 Hour Helpline |