Medtronic Insulin Pump Problems Receive FDA Warning
April 24, 2010
Insulin pumps are miniature medical devices worn by diabetics that provide a convenient delivery of insulin. The pumps replace the traditional daily injections via syringe or insulin pen. Many companies manufacture insulin pumps; however, Medtronic has had some serious set backs in their manufacturing process. The FDA issued a recall of the Medtronic Insulin Pump after the company determined that about 60,000 infusion sets used within the pumps were defective, and due to an air pressure problem, could supply too much insulin, not enough insulin, or no insulin at all. The FDA found the most common cause of death or injury was due to hypoglycemia and reported more than 29 cases of car accidents associated with the Medtronic Insulin Pump malfunctions. Patients lost consciousness or died while driving, and then crashed into other vehicles, drove off the road, ended up in lakes, and even slammed into buildings at high speed. Medtronic has issued a recall of approximately three million Medtronic Insulin Pumps to date, due to the air pressure defect.
FDA Criticizes Medtronic for Lack of Quality Control Procedures
The FDA also criticized Medtronic’s manufacturing processes, noting that the company lacked proper quality control. The report mentioned that Medtronic’s on-site medical professional, hired to determine if there were medical problems with the device, had only a high school diploma. The FDA initially discovered these shortcomings during an inspection in late 2008. The violations included failing to maintain process control procedures to make sure products conformed to specification, failing to ensure accurate records for each batch, failing to evaluate and investigate consumer complaints, and failing to report problems where malfunctions could have resulted in serious injury or death. The FDA letter also criticized the company for taking two years to recall the insulin pump after the company discovered some models were missing a key propellant. Medtronic initially identified this problem in May 2006, but failed to issue a recall or inform the FDA of the problem until May 2008.
If you have experienced a loss of consciousness, low or high blood sugar levels, or any other blood-sugar related illness while using a Medtronic Insulin Pump you may be entitled to financial compensation. Medtronic Insulin Pump Lawsuits are currently being filed across the country.
Susan Ardizzoni, Ph.D. holds a Doctorate in Biology with a major in Neuroscience (medical) and minors in Biochemistry, Physics, and Mathematics with experience in basic and clinical research. Although the author is not an attorney, this article was sponsored by the law firm of Bernstein Liebhard LLP and constitutes Attorney Advertising. To learn more about Medtronic Insulin Pump or Medtronic Insulin Pump Lawsuits please visit www.ConsumerInjuryLawyers.com