How To Remove Sure T Infusion Set

Consumers and health professionals are brash that Medtronic Australasia, in consultation with the TGA, has initiated a recall for product correction for Medtronic MiniMed Certain-T infusion sets with an expiry date on or earlier Apr 2022 (see below for a list of affected model numbers).

Please note that these products are not being removed from the market. Consumers volition have the selection of having the affected devices replaced free of charge, or keep using them in accordance with some additional instructions.

Medtronic MiniMed Sure-T 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.

There has been a slight increase in reports of cases where the needles of these infusion sets have broken during use.

If this occurs, insulin delivery is interrupted, but the pump will not alarm to notify the user. The interruption of insulin delivery can crusade hyperglycaemia, which if left untreated can cause serious health complications.

If a needle breaks during use information technology can also pb to infection.

In a small number of cases reported, a needle intermission has led to hospitalisation of the user to manage their blood glucose levels and/or to remove the needle.

The affected model numbers are:

MMT-860
MMT-862
MMT-863
MMT-864
MMT-865
MMT-866
MMT-870
MMT-873
MMT-874
MMT-875
MMT-876
MMT-883
MMT-884
MMT-885
MMT-886

Information for consumers

Medtronic Australasia has written to Medtronic MiniMed Certain-T infusion ready users to notify them of this issue and the deportment they tin have to address it.

If yous or someone y'all care for uses Medtronic MiniMed Sure-T infusion sets, check the box or pouch labels to run across if y'all have an affected device. These labels include a reference number relating to the model number, as well as the expiry engagement (marked with red boxes in the beneath images).

Medtronic MiniMed Sure-T infusion set box and pouch labels

If the reference number matches one of the affected model numbers listed to a higher place, and if the expiry date is on or before April 2022, you lot should take one of the two following alternatives:

Replacement – Call Medtronic Australasia on 1800 777 808 (select option 1) to arrange replacement of the infusion sets free of accuse.

Go on utilise – You can go along to use the affected products if yous advisedly review the Instructions for Use included with the product, as well as follow the below additional instructions:

Prior to use:
- Carefully remove the needle guard before inserting the infusion set. The needle guard should be removed without the use of any twisting or bending of the needle guard.
- Do not use the infusion set if the needle is aptitude or has been damaged.
- Do non curve the needle prior to insertion.
- Consult your health professional person for the proper insertion site.
During use:
- As always, it is essential to monitor your blood saccharide levels frequently using your blood glucose meter.
After use:
- Carefully remove the infusion set later use to avoid twisting or bending of the needle.
- Ensure the consummate needle is present on the used infusion fix before discarding it.
- Contact your wellness professional if yous suspect that a needle has broken off and remained under the skin.
- Proceed to monitor your blood carbohydrate.

If you have any questions or concerns about this event, speak to your diabetes nurse educator or other health professional. Alternatively, yous tin can contact Medtronic Australasia on 1800 777 808 (select pick one).

Data for health professionals

Medtronic Australasia has written to relevant health professionals and consumers for whom it has contact details advising of this issue.

If y'all are treating patients who use Medtronic MiniMed Certain-T infusion sets, delight ensure they are aware of this issue and the actions they tin accept to address information technology (encounter the 'Information for consumers' section above for specific instructions).

If y'all accept any questions or concerns nearly this issue telephone Medtronic Australasia on 1800 777 808 (select option 1).

Reporting issues

Consumers and health professionals are encouraged to written 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 lot are concerned about a possible agin consequence associated with a medical device.