In early June, Medtronic issued an urgent notification to patients and medical professionals concerning a “potential for over or under delivery of insulin if insulin or other fluids contact inside of Medtronic Paradigm Infusion Set Connectors.”
According to the FDA’s website, Medtronic is taking this action for the Medtronic MiniMed Paradigm Insulin Infusion Sets because of a potential safety issue that can occur if insulin or other fluids come in contact with the inside of the tubing connector. If this occurs it can temporarily block the vents that allow the pump to properly prime. This can result in too much or too little insulin being delivered resulting in hypoglycemia or hyperglycemia which can be severe and lead to serious illness. This failure can cause diabetic ketoacidosis.
The FDA Class I Recall, initiated on June 7th, affected products that were manufactured from October, 2001 through June, 2013 and distributed from December, 2001 through June, 2013. Patients are advised that if they notice anything unusual during the infusion set prime process such as the insulin continuing to drip from the tip of the infusion set cannula when priming has been completed, this may indicate that the connector vents are not working properly. Patients are encouraged to visit the FDA’s website to see if their device is affected by the recall.
According to reports, Amanda Sheldon, spokesperson for Medtronics, acknowledged that the company has received reports of patients brought to hospitals which may be related to this issue. The company has not confirmed yet if these cases were related or if there were deaths that occurred.
If you or a loved one may have been injured while utilizing Medtronic’s Minimed Paradigm Insulin Pump, you may have a legal claim against Medtronics. You can contact our law firm for a free consultation at (610) 941-4204 or on our website: www.pbmattorneys.com