The Paradigm MiniMed Insulin Pump and Continuous Glucose Monitoring System is an infusion pump for Type 1 diabetics. The pumps are designed to simulate the way the human body makes use of insulin by continuously infusing at a fixed rate, augmented by manual doses self-delivered by the user based upon their monitored glucose levels,however, when they are defective, the results can be devastating.
Last year alone, Medtronic, the manufacturer of insulin infusion pumps issued three separate recalls or “Urgent Medical Device Safety Notifications” concerning patient safety issues involving its and related equipment.
Have you had a serious reaction to a pump malfunction? Do you know someone who has been hospitalized or died while using an insulin pump? Some diabetics with illness or injury may not link their experience with what could be a pump defect or malfunction.
Contact our attorneys for a no cost, no obligation consultation to learn your legal options. Call 215-557-0099 or fill out this inquiry form to learn more.
The first recall, in April, 2013, involved a manufacturing defect which could allow water to infiltrate and damage the pump’s electronics. 428,000 units were involved.
Then in June, 2013 Medtronic issued an “Urgent Medical Device Safety Notification” to physicians and patients warning of the “potential for over or under delivery of insulin if insulin or other fluids contact the inside of the Medtronic Paradigm tubing connectors.” The fluids—which include insulin spilled during priming–can temporarily block the vents in the connector that allow the pump to properly prime.
The letter warned:
“[i]f these vents are blocked, this can potentially result in too much or too little insulin being delivered, which may cause hypoglycemia or hyperglycemia, which, in extreme cases, may cause loss of consciousness or death.
It is not presently known how many adverse event reports the FDA has received relating to these problems but i a sufficient number to warrant multiple and successive recalls and warnings. Similar recalls have been issued in Canada as well as the European Union.