Animas 2020 insulin pump devices are being recalled over a defect that may put diabetes patients at risk. Animas is Johnson & Johnson’s insulin pump unit.
The Animus 2020 insulin pump’s defect may result in unintended insulin delivery, said Fierce Medical Devices, which led the U.S. Food and Drug Administration (FDA) to deem Johnson & Johnson’s move a Class I recall. A Class I recall is the agency’s most serious designation and indicates that use of the recalled device could lead to serious injury, even death.
The Animas devices were manufactured from March 2012 to November 2012 and were constructed with a faulty component that leads to faulty alarms. The defect may also prompt patients to rewind, load, and prime the Animus insulin pump device. This may lead to an unnecessary infusion of medicine, according to Fierce Medical Devices, and places patients at increased risks for hypoglycemia. The pumps were also constructed with a software defect in which they become unusable as of December 21, 2015, said Animas.
The recall, initiated in January, advised customers to disconnect the 2020 Animas pump units from their bodies prior to resetting the Animas, and to contact Animas to arrange for a replacement pump. According to the agency, all lots of the recalled Animas devices are involved; devices were distributed March 1, 2012 – September 30, 2012. The 2020 Animas pump has been discontinued and the firm is urging customers to use its current model, the OneTouch Ping, Fierce Medical Devices said.
The Animas 2020 Insulin Pumps, which are used in the treatment of diabetes, deliver insulin into the patient’s blood, the FDA explained, adding that the false alarm or warning concerns either a “Loss of prime,” “Occlusion,” or “No cartridge selected.” Patients are advised to follow their Animas Owner’s Booklet’s safety instructions and to speak to Animas’ Product Fulfillment Center, toll-free, at 1.877.280.2339 from 6:00 a.m. to 12:00 a.m., Eastern Standard Time (EST), to schedule shipment of a free replacement pump. Animas Customer Technical Support Center may be reached, toll-free, at 1.866.793.5253.
This is not the first diabetes device Johnson & Johnson has issued in recent weeks and not the first time the health care giant has faced issues over an Animus insulin pump. The firm recently issued another diabetes recall for its LifeScan glucose monitor, recalling millions of its OneTouch VerioIQ devices. The firm also issued warnings stating that the devices were unable to warn patients whose blood sugar rose to seriously high levels, which led to one death, said Fierce Medical Devices.
Last year, Johnson & Johnson was under investigation over complication reports about its Animus insulin pump after a recall was implemented the prior year for its 2.0 mL Animas Insulin Pump Cartridges. That recall was initiated due to a defect that could leak insulin, causing an insulin under-dose. This fault could lead to high blood sugar and/or diabetic ketoacidosis—serious conditions that can lead to severe adverse reactions, even death.
Animas has not indicated if any adverse event reports related to the device’s defect have been received. The FDA advises consumers to report issues with the recalled Animas insulin pump through its online MedWatch system, Fierce Medical Devices said.