Medtronic MiniMed Infusion Sets including MiniMed Quick-set, MiniMed mio, MiniMed Silhouette and MiniMed Sure-T (specific lots)
Published 19 September 2017
Product
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.
Why it was 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.
Hazard
Over-delivery of insulin can cause hypoglycaemia (low blood glucose level), which can lead to serious health complications.
Source: Product Safety Australia. RecallMatch AU provides a screening summary and is independent of the ACCC.