Animas Insulin Infusion Pump Recall Issued Due to False Alarm, Warnings
A Class I recall has been issued for specific Animas insulin infusion pumps, due to a risk that a component in the pump may trigger a false alarm or warning, prompting the user to initiate a reset process that can be dangerous if not completed properly.
An Animas 2020 Infusion Insulin Pump recall was initially issued on January 3, but it was re-announced on April 4, after the manufacturer noticed a component in the pump may trigger a warning related to “loss of prime”, “occlusion”, “no cartridge detected”.
The insulin infusion pump problems pose a potential hazard for users, as it will prompt the user to run a complete “rewind, load and prime” process and if the pump is not detached from the user during this reset, an unintended amount of insulin may be administered to the user, posing serious health risks and even death.
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Animas 2020 Infusion Insulin Pumps manufactured from March 1, 2012 to November 30, 2012 are impacted by the recall. The pumps are equipped with a software limitation that only allows the pump to run until December 31, 2015. After this date the device will display a “Call Service Alarm”.
The FDA has designated the action as a Class I recall, which suggests that continued use of the product poses a serious risk of severe adverse health consequences or death.
The manufacturer advises consumers with the recalled Animas insulin pumps to carefully follow the rewind, load and prime process by detaching the machine from their body when the pump alarms. Consumers should also contact Animas’ Product Fulfillment Center at (877) 280-2339 to schedule a free shipping of a replacement pump. Users are also encouraged to report any adverse events to FDA’s MedWatch Safety Information and Adverse Event Reporting Program by completing and submitting the report online at www.fda.gov/MedWatch/report.htm or call 1-800-332-1088 to request the reporting form.
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