Johnson & Johnson's Animas 2020 Insulin Pump Recalled Due to Hypoglycemia, Death RiskApr 6, 2013
Animas Corporation, a Johnson & Johnson Company has recalled its 2020 insulin pumps. The Animas 2020 Insulin Pumps are used to deliver insulin directly into the patients’ blood for the treatment of diabetes. The U.S. Food and Drug Administration (FDA) assigned this as a Class 1 recall; the most critical. Class I recalls involve products deemed to be dangerous enough to cause serious adverse health consequences or death.
According to the FDA, Animas has identified a component issue affecting Animas 2020 Infusion Insulin Pumps manufactured from March 1, 2012 to November 30, 2012. This component issue may trigger the pumps to sound a false alarm or warning that may prompt the user to rewind, load and prime their device. This can lead to an unintended delivery of the insulin, putting the patient in danger of hypoglycemia, and other serious health risks.
Hypoglycemia is a condition that occurs when your blood sugar (glucose) is too low. Symptoms can vary based on how low your blood sugar level drops.
- Mild hypoglycemia can make you feel hungry or like you want to vomit. You could also feel jittery or nervous. Your heart may beat fast. You may sweat. Or your skin might turn cold and clammy.
- Moderate hypoglycemia often makes people feel short-tempered, nervous, afraid, or confused. Your vision may blur. You could also feel unsteady or have trouble walking.
- Severe hypoglycemia can cause you to pass out. You could have seizures. It could even cause a coma or death.
Furthermore, the Animas 2020 Insulin Pump has a software limitation. After December 31, 2015, the pump will no longer deliver insulin and will generate a “Call Service Alarm.” The FDA warns that this product may cause serious adverse health consequences, including death. This end of use date is not currently included in the product labeling.
This past January, the company sent a letter to Animas 2020 Insulin Pump customers notifying them about the problems with the device and giving them further instructions. J&J recently discontinued the Animas 2020 insulin pump, and are replacing it with their OneTouch Ping insulin pump.