| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00333-1 |
| Product Name/Description |
MiniMed 780G
Model Number: ACC-1527
Catalogue Numbers: MMT-1885 (R&D hardware packaging A2.xx), MMT-1895 (R&D hardware packaging A2.xx)
ARTG 376091
(Medtronic Australasia Pty Ltd - Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm) |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/04/2024 |
| Responsible Entity |
|
| Reason/Issue |
Some customers using MiniMed 780G insulin pumps received replacement battery caps not approved for use with their pump. These battery caps are not compatible with their insulin pumps as the caps are smaller in size than the battery caps approved for their pumps.
When used with their pump may result in the battery compartment not being securely sealed, allowing for moisture entering the pump and causing damage to the pump electronics. 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. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Consumers are to:
1. Gather their insulin pump and all battery caps in their possession.
2. Ensure they have a new battery available; do not remove the battery cap unless a new battery is available.
3. Look at the bottom and top of each battery cap and identify which battery cap is the approved battery cap for their pump using the pictures provided in the customer letter (provided to affected patients).
4. Discard all battery caps not approved for their pump. There is no need to return anything to Medtronic.
5. Install the approved battery cap onto the pump.
Health care professionals are to:
1. Assist patients in identifying the correct battery cap for their pump, installing the new battery cap on the insulin pump and discarding the previous battery cap if they are contacted by a patient for assistance. |
| Contact Information |
1800 777 808 - Medtronic 24-Hour Technical Support line |