| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01182-1 |
| Product Name/Description |
Medtronic MiniMed Infusion Sets
MiniMed Quick-set
MiniMed mio
MiniMed Silhouette
MiniMed Sure-T
ARTG Number: 119216 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/09/2017 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic has become aware of recent reports of potential over-delivery of insulin shortly after an infusion set change. Over-delivery of insulin can cause hypoglycaemia and in extreme cases, death. Medtronic has received reports of hypoglycaemia requiring medical intervention potentially related to this issue. Out of the millions of infusion sets sold each year, the reported incident rate requiring medical assistance related to this issue is less than 0.00005%. There have been no reports of death related to this issue.
An investigation by Medtronic has shown this issue can be caused by fluid blocking the infusion set membrane during the priming/fill-tubing process. A membrane blocked by fluid most likely occurs if insulin, alcohol, or water is spilled on the top of the reservoir or inside the tubing connector which then could prevent the infusion set from working properly. |
| Recall Action |
Recall |
| Recall Action Instructions |
For patients:
1. Users and HCPs with affected lot numbers (as confirmed with Medtronic using the dedicated webpage https://checklots.medtronicdiabetes.com
or Global Help Line 1800 777 808) are to cease using the sets and, in the absence of unaffected alternatives, follow the steps contained in the supplied letter.
Medtronic will replace the affected sets free of charge.
2. Cut out the bar codes on the boxes of recalled infusion sets (as per supplied picture) and return the bar codes in the reply paid envelopes that will be sent out with the new infusion sets.
3. Users are to discard, not return, the affected sets.
4. Customers are also requested to complete and sign the supplied Acknowledgment Form, and return as directed to Medtronic Australasia.
For further information, please see https://www.tga.gov.au/alert/medtronic-minimed-infusion-sets
This action has been closed out on 11/07/2019 |
| Contact Information |
1800 777 808 - Medtronic |