| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00402-1 |
| Product Name/Description |
Insulin Pump Battery Cap
MiniMed 640G Insulin Pump
Model numbers: MMT-1711, MMT-1712, MMT-1751, MMT-1752
MiniMed 670G Insulin Pump
Model numbers: MMT-1761, MMT-1762, MMT-1781, MMT-1782
MiniMed 770G Insulin Pump
Model numbers: MMT-1881, MMT-1882, MMT-1891, MMT-1892
MiniMed 780G Insulin Pump
Model numbers: MMT, 1885, MMT-1886, MMT-1895, MMT-1896
ARTG's 308140, 332201, 376091 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/05/2024 |
| Responsible Entity |
|
| Reason/Issue |
The previous battery cap (model ACC-1527), used on previous case insulin pumps, has a contact problem that can potentially result in an incomplete battery connection, leading to no power source to the pump. When the pump detects no power source, an “Insert battery” alarm will occur, and insulin delivery will immediately stop. After 10 minutes, the alarm sound will increase to a siren, and the pump will turn off.
If the pump stops delivery of insulin due to power loss, this could lead to varying degrees of high blood sugar, including diabetic ketoacidosis (DKA).This action supersedes RC-2022-RN-00725-1. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are to:
1. Please contact their study site to receive the new battery cap (model ACC-1529) and follow the instructions in their letter to replace their current battery cap with the new cap provided from the study site and discard any previous battery caps.
Health care professionals are to:
1. Order the new battery cap for participants using previous case insulin pumps by visiting the Clinical Online store.
2. Contact their study participants and assist them in identifying the new battery cap, installing the new battery cap on their previous case pump and discarding the previous battery cap per the instructions provided in the patient letter. |
| Contact Information |
1800 777 808 - Medtronic 24-Hour Technical Support |