Insulin infusion pump recalled for false alarm, warning sound

Animas 2020 Infusion Insulin Pumps have been recalled, according to an FDA Med Watch report. The recall is due to a malfunction affecting products manufactured from March 1, 2012 to November 30, 2012.

According to the FDA MedWatch report, the Animas 2020 Infusion Insulin Pump may sound a false alarm or warning related to one of the following:

“Loss of prime”
“Occlusion”
“No Cartridge detected”

“If you receive any of these alarms, the pump may prompt you to complete the rewind, load and prime sequence to clear this alarm. Failure to follow the pump’s safety instructions and disconnect your infusion set from your body before the ‘rewind, load and prime’ steps can lead to unintended delivery of insulin, placing you in danger of potential serious health risks, such as hypoglycemia,” the report said.

In addition to this issue, the pump also has a software limitation that will impact the ability of the pump to function past December 31, 2015. According to the report, the pump will no longer deliver insulin and generate a “Call Service Alarm,” after this date.

Health care providers and patients are recommended to report any adverse events or side effects related to the use of the product to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program by calling 1-800-332-1088 or going to www.fda.gov/MedWatch/report.htm.

For more information:

FDA MedWatch Alert. Accessed April 5, 2013.

Recall Notice. Accessed April 5, 2013.