Medtronic Insulin Pump
Insulin Pump Criteria
- Used any of the following Medtronic MiniMed insulin pump infusion sets prior to April 2017
- Paradigm
- Synchromed
- Sure-T
- Mio
- Silhouette
- Quick-Set
- Suffered from any of the following injuries while using the MiniMed
- Hypoglycemia
- Seizures
- Diabetic coma
- Death
- No legal representation
Insulin Pump Background Information
Manufacturer
Medtronic
Treatment for
Type 1 and type 2 diabetes to control insulin in diabetic patients without the use of needles. The MiniMed insulin sets and infusion pumps are intended to provide patients with better glucose control by delivering accurately metered insulin dosages via the device’s electronic brain. Medtronic states that the devices will improve HbA1c management, reduce hypoglycemic events and significantly improve glycemic variability.
Issues
The MiniMed devices consist of a small electronic device and an infusion set connected to the electronic device by a tube. The infusion set delivers insulin to the patient in measured doses. The vent membrane in the infusion set can become clogged after priming the tube and can result in an over-delivery of insulin to the unwitting patient. Overdosing a diabetic with insulin is causes hypoglycemia and can lead to seizures, coma and death.
Recalls
- Medtronic recall letter : http://www.medtronicdiabetes.com/res/img/pdfs/MVB-Patient-Notification-Letter.pdf
- FDA recall letter : https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158700
Timeline of Events
- June 2013 : Class I recall for 11 million MiniMed Paradigm infusion sets due to a malfunction that can cause the device to over- or under-deliver insulin
- August 2013 : A warning letter was sent by the FDA to the Medtronic Paradigm manufacturing facility stating that the factory was not up to proper standards
- April 2014 : Medtronic recalls another 550,000 Paradigm insulin infusion pumps after receiving reports of accidental button pressing on the devices that can change the insulin delivery dosage
- February 2015 : The FDA filed a consent decree against Medtronic and two corporate officers for “repeatedly failing to correct violations related to the manufacture of the Synchromed II”
- September 2017 : Medtronic sends out a patient notification letter urgently warning that certain devices are being recalled and advising patients to check their device to determine if theirs is part of the recall
- November 2017 : The FDA announces a Class 2 recall for over 9.5 million MiniMed infusion pumps and sets due to the over-delivery of insulin in diabetic patients
Symptoms & Side Effects
- Racing heartbeat
- Pale skin
- Shakiness
- Fatigue
- Headaches
- Extreme hunger
- Irritability
- Anxiety
- Excess sweating
- Confusion
- Vision disturbances
Injuries
- Hypoglycemia
- Seizures
- Diabetic coma
- Death
