MiniMed Silhouette and MiniMed Sure-T infusion sets
Safety advisory due to potential for tubing disconnection.
Consumers and health professionals are advised that Medtronic Australasia, in consultation with the TGA, is issuing a safety alert to notify of a potential increase in the number of tubing disconnections involving MiniMed Silhouette and MiniMed Sure-T infusion sets.
Infusion sets are used in conjunction with a pump to deliver a continuous dose of insulin to help people with diabetes maintain normal blood glucose levels.
If tubing becomes detached, insulin delivery is interrupted. The interruption of insulin delivery can cause hyperglycaemia, which, if left untreated, can have serious health effects.
The issue was identified following an increase in the number of reports of infusion set disconnection worldwide. The number of disconnections that have occurred is still very low.
This issue also affects the following two other infusion set brands produced by the same manufacturer:
The infusion sets are not being recalled.
Sites where the tubing may become detached.
Information for consumers
Medtronic Australasia has written to MiniMed Silhouette or MiniMed Sure-T infusion set users to notify them of this issue and the precautions they need to take to keep using the sets. If someone you care for uses one of these infusion sets, ensure they are aware of this issue.
Users are advised to:
- closely follow the Instructions for Use (IFU) included in the product box
- regularly check the tubing near the connection/disconnection point as shown in the diagram above to make sure it is not loose
- monitor blood sugar levels frequently using a blood glucose meter
- check both the tubing connection and blood sugar levels immediately before bedtime to confirm insulin delivery.
If the tubing becomes detached:
- do not attempt to reattach the tubing
- replace the infusion set immediately
- treat any high blood sugar level as per the treating health professional's advice
- keep the broken infusion set and telephone Medtronic Australasia on 1800 777 808 to arrange for return and replacement.
The device is not designed to sound an alarm if the tubing becomes detached.
If you have any questions or concerns about this issue, telephone Medtronic Australasia on 1800 777 808. Alternatively, you can speak to your diabetes nurse educator or other health professional.
Information for health professionals
Medtronic Australasia has written to relevant health professionals and consumers for whom it has contact details advising of this issue.
If you are treating patients who use MiniMed Silhouette or MiniMed Sure-T infusion sets, ensure they are aware of this issue.
Advise patients of the actions they should take to continue using the infusion sets. These actions are listed in the Information for consumers section above.
If you or your patients have any questions or concerns about this issue telephone Medtronic Australasia on 1800 777 808.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.