Animas, a subsidiary of Johnson & Johnson, warned medical device regulators in Europe that some of the company’s insulin pumps contain a serious software flaw. At midnight on December 31st, 2015, affected insulin pumps will stop working.
According to information from the company, the impacted insulin pumps are no longer distributed in the United Kingdom. Affected models include the Animas IR1250, IR1200 and IR2020. Starting January 1st, 2016, these devices will no longer deliver insulin for patients. Instead, a notice will be generated that says, “call service alarm.” Information on this software glitch was released by the Medicines & Healthcare Products Regulatory Agency in the United Kingdom.
In November of 2012, Animas began to warn patients of the dangers associated with its insulin pump software programming. The company has a standing offer to replace affected devices with a warranty. Insulin pump users with expired warranties may not qualify for the free unit replacement.
In a warning letter, Animas stated, "We are also committed to providing assistance to our patients whose warranties will expire prior to Dec. 31, 2015." The warning letter continued, "Between now and the end of 2015, we will be proactively reaching out to all our out-of-warranty Animas 2020, Animas IR1250 and Animas IR1200 to remind them of this issue and to ensure their transition to a newer pump model."