Medtronic MiniMed infusion sets

Recall - potential for over-delivery of insulin and risk of hypoglycaemia

15 September 2017

Consumers and health professionals are advised that Medtronic Australasia, in consultation with the TGA, is recalling specific lots of Medtronic MiniMed infusion sets, including MiniMed Quick-set, MiniMed mio, MiniMed Silhouette and MiniMed Sure-T.

Medtronic MiniMed infusion sets are used in conjunction with an insulin pump to deliver a continuous dose of insulin to help people with diabetes maintain normal blood glucose levels.

There have been recent reports of potential over-delivery of insulin shortly after an infusion set change. Over-delivery of insulin can cause hypoglycaemia (low blood glucose level), which can lead to serious health complications.

Subsequent investigations have found that this issue may 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 could prevent the insulin set from working properly.

Updated infusion sets contain a new and enhanced membrane material that significantly reduces this risk.

People who have Medtronic MiniMed infusion sets are instructed to check the lot numbers either by visiting a Medtronic website or by calling Medtronic to see if their products are affected (see the 'Information for consumers' or 'Information for health professionals' sections below for further details).

Information for consumers

Medtronic Australasia has written to consumers who have Medtronic MiniMed infusion sets to provide further information about this issue, include details of the recall procedure and instructions regarding the priming/fill-tubing process (called 'Key Steps').

If you or someone you provide care for uses Medtronic MiniMed infusion sets, go to https://checklots.medtronicdiabetes.com to determine if the infusion sets you have are affected by this recall and, if you do, to arrange replacements. You will need to enter the REF and LOT numbers for all infusion sets you have. Alternatively, you can call Medtronic on 1800 777 808 (press option 1).

recall instructions to check Medtronic MiniMed infusion sets

Unless you do not have access to a suitable alternative, do not use infusion sets that are affected by this recall.

If you are unable to access infusion sets that are not affected by this recall, you can use the recalled products but must carefully follow the 'Key Steps' provided in the recall letter. This information is also available at https://www.medtronic-diabetes.com.au/customer-support/safety-information. Alternatively, if you do not feel comfortable using these products, you can choose to revert to your back-up injection plan until your replacement infusion sets arrive.

Affected users are being instructed to not return any infusion sets. Instead, you are asked to cut out the barcodes on the boxes of the recalled products and send them to Medtronic in a reply paid envelope that will be sent out with your replacement infusion sets.

Once you have suitable alternative products, you should dispose of all recalled infusion sets you have.

If you have any questions or concerns about this issue, speak to your diabetes nurse educator or other health professional. Alternatively, you can call Medtronic on 1800 777 808 (press option 1).

Information for health professionals

Medtronic Australasia has written to health professionals who supply Medtronic MiniMed infusion sets to provide further information about this issue, include details of the recall procedure and instructions regarding the priming/fill-tubing process (called 'Key Steps').

If you treat patients who use Medtronic MiniMed infusion sets, advise them of this issue. Patients and health professionals need to go to https://checklots.medtronicdiabetes.com to determine if the infusion sets they have are affected by this recall and, if so, to arrange replacements. You will need to enter the REF and LOT numbers for all infusion sets you have. Alternatively, you can call Medtronic on 1800 777 808 (press option 1).

If you have any questions or concerns about this issue, call Medtronic on 1800 777 808 (press option 1).

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.