The U.S. Food and Drug Administration (FDA) issued a safety alert and class I recall April 5 for the Animas 2020 Infusion Insulin Pump. The pump is used to deliver insulin directly into the blood of diabetics. The recalled pumps were made between March 1 and Nov.30, 2012.
Part of the pump’s mechanism is defective and causes it to sound a false alarm or warning related to:
- “Loss of prime”
- “Occlusion”
- “No cartridge detected”
In order to clear the alarm, the diabetic patient must complete the sequence to “rewind, load and prime.” If the patient does not disconnect the pump from his or her body before this sequence begins, the defect can cause the unintended delivery of insulin into the blood. This might lead to hypoglycemia or low blood sugar.
In addition, because of the pump’s software design, it will fail to properly function after Dec. 31, 2015, and at this time will discontinue delivering insulin and produce a call service alarm.
Patients who have the device should call Animas’ Product Fulfillment Center at 877-280-2339 between 6 a.m. and 12 a.m., EST to schedule receiving a free replacement. To contact the Technical Support Center, call 866-793-5253.
If you or someone you love has suffered injuries or side effects of a defective insulin pump or other medical device, you may qualify for financial compensation. Medical device defects can result in serious injuries and death. To learn more, contact the injury lawyers at Flood Law Group for help today.