The Federal Drug Administration has assigned its most serious Class I tag to a recent recall of Johnson & Johnson’s Animas Infusion Insulin Pumps, saying the problem could lead to serious injury and death. J&J is recalling its 2020 devices, warning that a malfunction may lead to unintended insulin delivery, putting patients at a significant risk.
The Animas 2020 pumps, which are used to deliver insulin directly into the patient’s blood for the treatment of diabetes, have a faulty component that can lead to erroneous alarms. They also prompt patients to rewind, load and prime them, which can trigger unwanted infusion and put users at risk for hypoglycemia. In addition, the insulin pumps have a software glitch that will render them unusable on December 31, 2015. After this date, the pump will no longer deliver insulin, leading to the possibility of serious health consequences.
In January, Animas launched the recall of 384,000 pumps, which were distributed between March 1, 2012 and November 30, 2012. The FDA noted that all lots of the recalled product were involved. Customers were instructed to disconnect the device from their bodies before resetting it and to immediately contact the company for a replacement. They have also been told to follow the safety instructions in the Animas Owner’s Booklet and to speak to Animas’ Product Fulfillment Center at 1-877-280-2339 between 6:00 a.m. and 12:00 a.m., Eastern Standard Time, to schedule shipment of a free replacement pump.
The FDA has warned Animas that it could face fines and other sanctions for continuing to see defective insulin pumps and delaying the disclosure of serious injuries to patients. It has ordered them to provide an explanation for why they kept selling the pumps that were known to be faulty and to submit a plan that will promptly rectify its failure to report these injury cases, in which the pump may have contributed to serious injury or death. The patients referenced were hospitalized with dangerously high blood sugar, respiratory failure and coma, and the life-threatening complication diabetic ketoacidosis, which is cause by lack of insulin to break down blood sugar. The FDA is asking customers to report any health problems that may possibly be related to use of the Animas insulin pump through its online MedWatch system.
This is the second recall for J&J in recent months. The company was also forced to remove the LifeScan OneTouch VerioIQ devices from shelves. These faulty meters fail to alert patients with dangerously high blood sugar levels, resulting in at least one death.
Animas insulin pump recall
Posted by advocateadmin in News
The Federal Drug Administration has assigned its most serious Class I tag to a recent recall of Johnson & Johnson’s Animas Infusion Insulin Pumps, saying the problem could lead to serious injury and death. J&J is recalling its 2020 devices, warning that a malfunction may lead to unintended insulin delivery, putting patients at a significant risk.
The Animas 2020 pumps, which are used to deliver insulin directly into the patient’s blood for the treatment of diabetes, have a faulty component that can lead to erroneous alarms. They also prompt patients to rewind, load and prime them, which can trigger unwanted infusion and put users at risk for hypoglycemia. In addition, the insulin pumps have a software glitch that will render them unusable on December 31, 2015. After this date, the pump will no longer deliver insulin, leading to the possibility of serious health consequences.
In January, Animas launched the recall of 384,000 pumps, which were distributed between March 1, 2012 and November 30, 2012. The FDA noted that all lots of the recalled product were involved. Customers were instructed to disconnect the device from their bodies before resetting it and to immediately contact the company for a replacement. They have also been told to follow the safety instructions in the Animas Owner’s Booklet and to speak to Animas’ Product Fulfillment Center at 1-877-280-2339 between 6:00 a.m. and 12:00 a.m., Eastern Standard Time, to schedule shipment of a free replacement pump.
The FDA has warned Animas that it could face fines and other sanctions for continuing to see defective insulin pumps and delaying the disclosure of serious injuries to patients. It has ordered them to provide an explanation for why they kept selling the pumps that were known to be faulty and to submit a plan that will promptly rectify its failure to report these injury cases, in which the pump may have contributed to serious injury or death. The patients referenced were hospitalized with dangerously high blood sugar, respiratory failure and coma, and the life-threatening complication diabetic ketoacidosis, which is cause by lack of insulin to break down blood sugar. The FDA is asking customers to report any health problems that may possibly be related to use of the Animas insulin pump through its online MedWatch system.
This is the second recall for J&J in recent months. The company was also forced to remove the LifeScan OneTouch VerioIQ devices from shelves. These faulty meters fail to alert patients with dangerously high blood sugar levels, resulting in at least one death.