| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-00725-1 |
| Product Name/Description |
All MiniMed 640G, 670G, 700, 770G, and 780G Insulin Pumps
ARTGs 95763, 308140, 332201 and 376091 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
1/06/2022 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic Diabetes Signal Detection observed a complaint signal for battery cap cracked/damaged (BA01) for MiniMed 600 series pumps. Per the failure analysis of the returns, damaged/broken/loose/missing battery cap contact was observed. If the gold contact falls off while the user is changing the battery, the “Insert battery” alarm will not clear automatically when the user inserts a new AA battery as the circuit is still not complete. The alarm will escalate to a siren in 10 minutes and then the pump will shut down and not power up until the circuit is established.
The issue may potentially lead to major hyperglycemia and Diabetes Ketoacidosis (DKA). |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Medtronic are informing customers that Medtronic is working on a new design for the cap which will be available by Q1 2023.
Meanwhile customers are advised by Medtronic to follow the interim actions outlined in the customer letter (will be provided only to the impacted customers by Medtronic). |
| Contact Information |
1800 777 808 - Technical Support - Medtronic |