April 9, 2013
The U.S. Food and Drug Administration has bumped the voluntary recall on Animas 2020 Insulin infusion pumps to a Class I status. This means use of the Defective Medical Device could result in serious injury or death.
According to an article from Medpage Today, the recall affects all pumps that were manufactured between March 1 and November 30 of last year. The units are equipped with an alarm that sounds when insulin cannot be delivered to the patient’s blood stream for any reason. Unfortunately though, the devices have reportedly given false alarms that resulted in patients getting an unexpected dosage of the drug.
The product also has a problem with its programming that will prevent the unit from working past the end of the year 2015.
The FDA has stated a diabetic who receives too much insulin can experience a range of adverse health events, including hypoglycemia or even death.
Anyone in possession of an affected unit has been instructed to contact the product’s manufacturer to receive a free replacement device. Any adverse events associated with the use of the product should be reported to the FDA immediately.
The Dallas Personal Injury Attorneys with Ferrer, Poirot & Wansbrough would encourage anyone who has been harmed by the use of a defective medical device to also discuss their legal rights with a qualified attorney as soon as possible.