| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00167-1 |
| Product Name/Description |
MiniMed 640G Insulin Infusion Pump (with software version 2.6)
ARTG Number: 95763 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
13/02/2017 |
| Responsible Entity |
|
| Reason/Issue |
A software issue affecting some MiniMed 640G insulin infusion pumps that could prevent the internal battery from charging has been identified. Should this issue occur, an alarm will be triggered and users will see a "Power error detected" message accompanied by the number “25”, displayed on the pump screen. Users are advised not to ignore this alarm and error message, which means that their pump has now stopped delivering insulin. If not, users could develop high blood sugar levels (hyperglycaemia). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Medtronic has contacted users who could potentially be affected and relevant health professionals to provide further information about this issue. Medtronic is advising users who experience this error to phone the Medtronic 24 hour Helpline (1800 777 808 - option 1). Users will be guided to troubleshoot to determine the cause of the error message and to perform a pump reset process which will reset the condition that caused the software anomaly. If the error cannot be corrected, the pump will be replaced.
TGA will soon be publishing a web statement about this issue.
This action has been closed out on 11/10/2018 |
| Contact Information |
1800 777 808, Option1 - Medtronic Customer Support Team |