A U.S. Food and Drug Administration panel wants more information about problems involving insulin pumps, according to a recent article from HealthDay News. There were approximately 375,000 diabetics using insulin pumps in the U.S. as of 2007.
Many Type 1 diabetics rely on insulin pumps to supply their body with the hormone. People with Type 1 diabetes do not produce insulin, which helps regulate the sugar levels in the blood. The pump helps provide a steady drip of insulin into the blood as well as larger doses to counteract rising blood sugars after meals.
Dow Jones recently reported that the FDA says it has seen a sharp increase in the number of “adverse events” associated with insulin pumps. Medical device makers are required to tell the FDA when a pump malfunctions or causes harm or death to a patient. Since 2006, there have been 16,849 reported “adverse events,” including 310 deaths and 12,093 injuries. There have also been 4,294 reported malfunctions. There have been 18 pump recalls since 2004.
The FDA panel says it needs the additional information to determine if the rise in events is due to defects in the pump’s technology or due to users not following pump guidelines. Too much insulin can cause a patient’s blood sugar to go too low, potentially leading to seizures, diabetic coma and even death. If a pump shuts down unexpectedly and fails to deliver the expected insulin, blood sugar levels can rise dramatically, also potentially causing diabetic coma, diabetic ketoacidosis and even death.
Diabetes News Hound has reported on insulin pump problems in the past (See Diabetes News Hound Aug. 26, 2009 “Death By Insulin Pump” and Diabetes News Hound Aug. 28, 2009 “More Insulin Pump Problems Reported by Readers“)
To receive free news updates from Diabetes News Hound delivered straight to your Inbox, sign up here.
If you already receive the free Alerts, spread the word by telling a friend to sign up here.
