PRA number
2017/16329
Published date
Product description
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.
Reasons the product is recalled
There have been recent reports of potential over-delivery of insulin shortly after an infusion set change.
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.
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.
The hazards to consumers
Over-delivery of insulin can cause hypoglycaemia (low blood glucose level), which can lead to serious health complications.
What consumers should do
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. If you have affected infusion sets, follow the instructions on the website to arrange replacements. You will need to enter the REF and LOT numbers for all infusion sets you have. See the attached photographs of the box and pouch labels for the location of the REF and LOT numbers. Alternatively, you can call Medtronic on 1800 777 808 (press option 1).
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-informati…. 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).
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. If you have affected infusion sets, follow the instructions on the website to arrange replacements. You will need to enter the REF and LOT numbers for all infusion sets you have. See the attached photographs of the box and pouch labels for the location of the REF and LOT numbers. Alternatively, you can call Medtronic on 1800 777 808 (press option 1).
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-informati…. 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).
Supplier
Where the product was sold
Nationally
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.