The Medtronic MiniMed Paradigm Insulin Pump is designed to deliver insulin to diabetes patients, making daily injections unnecessary. Serious injury and death, from potentially defective or malfunctioning parts of the device, are being reported to the FDA.
MiniMed Paradigm Insulin Pumps are designed to deliver insulin continuously, taking the place of daily, manual injections of insulin
MiniMed insulin pumps are about the size of a cell phone and can be worn on a belt or placed in a pocket. The pump connects to the patient’s body with an infusion set. The set consists of a needle going into the abdomen, secured by an adhesive pad and connecting to the pump with a thin plastic tube.
The infusion set tubing is designed to be replaced every several days. However, increasing incident reports of blocked sets has prompted the FDA to issue a Class 1 recall, the most serious, advising patients and health care professionals of the potential for under or over delivery of insulin. Medtronic alerted patients and healthcare officials by sending an “Urgent Medical Device Safety Notification” letter and
If you or someone you know has a Medtronic MiniMed Insulin Pump and is experiencing problems or who has died, contact the defective medical device attorneys at the Harman Law Firm. Call (404) 554-0777 or fill out the “contact us” form at the top right of this page. There may be a time limit to file a claim, so call now.
The following symptoms can occur with the incorrect dose of insulin.
Too much or too little insulin may cause fainting, seizure, or coma. Here are the warning signs for both:
- Rapid heartbeat
- Shaking, trembling
- Double vision/blurry vision
- Headache, confusion
- Mood shifts, ranging from angry to nervous
- Fatigue, interrupted sleep
- Pale or tingling skin
Seek medical attention immediately if you suspect you have a problem with your insulin pump are experiencing any of these symptoms.
The FDA recommends:
“Patients, if you 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.”
What to look for in the pump and infusion set
According to the FDA, if insulin or other fluids come in contact with the inside of the tubing connector it can temporarily block the connector 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.
Or in the case of Harman Law’s client, her daughter’s death.
- The Harman Law Firm represents clients across the country who have been injured by dangerous and defective drugs and medical devices.
Medtronic MiniMed Paradigm Insulin Infusion Sets: Class 1 Recall – Potential for Over or Under Delivery of Insulin” FDA MedWatch Safety Information and Adverse Event Reporting Program, July 12, 2013
Medtronic Urgent Medical Device Safety Notification, June 10, 2013