Recall on Medtronic MiniMed infusion sets

Tuesday, 19 Sep 2017

A TGA Safety Alert has advised that Medtronic Australasia is recalling specific lots of their Medtronic MiniMed infusion sets.

The recall includes Medtronic MiniMed Quick-set, MiniMed mio, MiniMed Silhouette and MiniMed Sure-T infusion sets. It follows reports of potential over-delivery of insulin after an infusion set change.

Subsequent investigations have found that the issue may be caused by fluid – most likely insulin, alcohol or water – blocking the infusion set membrane during the priming/fill-tubing process.

Updated infusion sets contain a new and enhanced membrane material that significantly reduces this risk of over-delivery of insulin.

The TGA has advised health professionals to tell their patients they will need to check the reference and lot numbers of their products to see if they are affected by the recall.

Patients and health professionals can check the REF and LOT numbers of infusion sets, and arrange for replacements if necessary, by visiting a dedicated Medtronic website or by calling Medtronic 1800 777 808.

Patients who do not have access to unaffected insulin infusion sets, should carefully follow advice for using their current products or revert to their back-up injection plan.

The company have said the reported incidence rate requiring medical assistance related to this issue is less than 1 in every 2 million infusion sets.

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