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A MiniMed Paradigm insulin pump is a device about the size of a pager that diabetics can wear to deliver insulin at a continuous rate to their bodies. The pump is not implanted in the body and can be worn on a belt or carried in a pocket.
The system for delivering the insulin consists of:
Medtronic, Inc., the manufacturer of the device is headquartered in Minneapolis. The company reports that insulin pump therapy is:
The insulin pump replaces the need for diabetics to inject insulin, which must be done numerous times throughout the day. The pump system monitors glucose with a small implantable sensor that is connected to a transmitter. The transmitter sends information to the pump about the patients’ glucose levels and allows them to monitor their glucose levels throughout the day. Depending upon their activity (for example eating or exercising), patients can push a button to increase the amount of glucose that is delivered.
On July 10, 2009, the company issued a voluntary recall of specific lots of Quick-set ® infusion sets, the a thin plastic tube that carries insulin from the reservoir of the pump to the body of the patient. In a bulletin, the U.S. Food and Drug Administration (FDA) reported that the sets may not allow the pump to vent air pressure properly. As a result, the pump might deliver too much or too little insulin and possibly cause serious injury or death.
The sets being recalled are from Lot 8 and have reference numbers:
The FDA said the lot number is marked clearly on the product box label and on each individual infusion package set. Medtronic reported that about two percent of the Lot 8 sets might not work properly.
If you feel you have been harmed by using the recalled infusion sets from Lot 8, as listed above, you may be able to claim damages by speaking with our Medtronic lawyer. You can find out more information about your particular legal situation by contacting one of our legal professionals today.
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