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Medtronic: Insulin Pumps Not Waterproof

Sep 10, 2003 | AP

Medtronic Inc. warned doctors and patients that two of its insulin pumps that were sold as waterproof can develop stress cracks over time and take in water.

The company said people should not wear Medtronic MiniMed Paradigm 511 and Paradigm 512 insulin pumps while swimming or participating in other water activities where the pump would be submerged because the water can cause the pump to shut down.

Spokeswoman Deanne McLaughlin said Wednesday that the pumps, launched a year ago, were tested in 3-foot-deep water for 30 minutes at the MiniMed manufacturing plant in Northridge, Calif. They were considered waterproof when shipped, she said.

"But over time, as people have used the pumps, the Paradigm has developed stress cracks," McLaughlin said Wednesday. This summer, when people began swimming more, Medtronic noticed more pumps were being returned due to water exposure, she said.

"It's OK if it's splashed or dunked in water briefly," McLaughlin said.

Medtronic also recommends that patients disconnect the pumps when showering.

An insulin pump consists of a pump reservoir filled with insulin, a small battery operated pump and a computer chip that allows the user to control how much insulin the pump delivers. It is contained in a plastic case about the size of a beeper connected to the body by a thin plastic tube inserted just under the skin.

The pump delivers a small amount of insulin continuously to keep blood sugar levels stable between meals and overnight. The user sets the pump to deliver additional insulin when food is eaten.

If the pump turns off due to water damage, the pump's screen will go blank and its activation buttons won't work. If that happens, patients should check their blood sugar levels and treat any high blood glucose with an insulin injection, the company said.

"If there's anything that happens to the pump with water, we definitely will replace the pump," McLaughlin said.

Medtronic voluntarily notified the Food and Drug Administration of the problem and sent out letters to physicians and patients using the pumps.

"Right now, we are going through and changing everything on our Web site to reflect (the change) and we're reviewing other sites that may have it to notify them," McLaughlin said.

Medtronic hopes to develop a future model that will remain waterproof over time, she said.

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