On April 5, 2013, the US Food and Drug Administration (FDA) reclassified Animas Corporation’s voluntary January recall of the Animas 2020 insulin pump as a class I recall (the most serious type of recall). The recall was initiated because of a defect that may cause the pump to sound false alarms, potentially leading to serious medical events.
All lots of the pump manufactured from March 1, 2012, through November 30, 2012, may contain a component that can trigger a false alarm or warning regarding a “loss of prime,” “occlusion,” or “no cartridge detected.” The user may be required to rewind the motor, load the cartridge, and prime the infusion set to clear the alarm. Failure to follow the pump’s safety instructions and disconnect the infusion set before taking the “rewind, load, and prime” steps can lead to an unintended delivery of insulin, placing the user at risk of a serious health risk such as hypoglycemia (low blood glucose).
According to Animas, users are not at any risk from this component malfunction as long as they follow the provided safety instructions and disconnect the infusion set from their body when rewinding the motor (periodically required to align the insulin cartridge and piston rod), loading the cartridge, or priming the infusion set.
The pump also has a software malfunction that will prevent it from working past December 31, 2015. After this date it will no longer deliver insulin and will generate a “call service alarm.”
Animas Corporation notified the FDA of the recall in December 2012 before beginning the process of notifying customers, health-care providers, distributors, and partners on January 3, 2013.
Those using the Animas 2020 pump are advised to call the Animas product fulfillment center at (877) 280-2339 between 6 AM and 12 AM EST to schedule shipment of their free replacement pump. Those with technical questions or who wish to report a concern should call the customer technical support center at (866) 793-5253.
Health-care professionals and users of the pump are encouraged to report side effects and adverse events related to its use to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program, either online, by faxing a completed reporting form to (800) FDA-0178 (332-0178), or by mailing a completed form to the address printed on the form.
For additional information, visit the FDA Web site or the Animas Web site.
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