Important Warning for Diabetic Patients in Kentucky
Medtronic has issued a large global recall of its diabetic insulin pump infusion devices. This recall will potentially affect every Kentucky resident that is currently using a Medtronic MiniMed insulin pump system.
The global voluntary recall of Medtronic’s diabetes infusion sets includes all models of Medtronic MiniMed insulin pumps. The period of time for the recall includes devices manufactured before April 2017.
This recall will affect thousands of devices already being used by patients in Kentucky and across the United States. This is a very serious recall as the defect in the device can cause serious adverse effects and even death.
Defective Vent Membranes Are Leading to Incorrect Insulin Dosages and Hypoglycemia
The problem is a defective vent membrane that can become blocked by fluid build-up when the pump is primed after an infusion set change is made. If the blockage occurs, the pump can give the patient too much insulin which can lead to hypoglycemia (low blood sugar) which can cause serous adverse physical problems and in some cases coma or death.
The component at the center of this recall is now discontinued but there are thousands of devices already on the market with this dangerous competent in place. The company is hoping that the new design update will reduce or eliminate the risk of this faulty device delivering too much insulin to patients after they perform an infusion set change. The company contacted the FDA to explain their concerns and share information on the problem and its associated risks. The recall was issued in the fall of 2017.
The Dangers of Hypoglycemia
Hypoglycemia is a constant worry for diabetics. Also known as low blood sugar, hypoglycemia occurs when the level of glucose in your blood drops below a normal level. This is typically a level of 70 milligrams per deciliter or less. However, many patients’ normal numbers may vary depending on their particular condition.
Symptoms of low blood sugar can develop quickly and without warning. In some cases, patients may not experience any symptoms. This is a very dangerous situation because the lack of symptoms does not mean that damage to the body isn’t occurring. When blood sugars become too low, patients need to be treated immediately as this is a medical emergency due to the dangers it presents.
Warning Signs and Symptoms of Hypoglycemia Include:
- Lack of concentration
- Poor coordination (stumbling or falling)
- Fainting (passing out)
- Cardiac arrest
- Numbness in the mouth or tongue
- Shaky or jittery movements
- Blurred vision
- Irregular heart beat
Patients with a defective device should receive instructions from Medtronic or their physician concerning what they should do to have their device corrected or replaced with a safe device.
How to Tell if Your Medtronic MiniMed Insulin Pump Has Been Recalled
To determine if you have an affected device, you will need to check your MiniMed infusion set REF number and LOT number to see if the device is a recalled product. This information will be located on your box and pouch labels. Click the button below to read the recall notice provided by Medtronic, and to learn more about whether your device is included and what steps to take next.
Read Medtronic's Recall Notice Here
Our Attorneys Are Here to Help Kentucky Residents Affected by This Insulin Pump Recall
If you are unsure if your device is part of the recall our office can help. Please do not hesitate to contact us for a FREE CASE CONSULTATION. Gray and White law has helped hundreds of clients injured by defective medical devices. If believe you or a loved one has been injured by a Medtronic MiniMed infusion set contact our office today to discuss your rights.