Johnson & Johnson (NYSE:JNJ) subsidiary Animas Corp. warned European regulators that certain of the company’s ambulatory insulin pumps contain a software flaw that will render the devices defunct on the stroke of midnight on December 31, 2015.
The Animas IR1200, IR1250 and 2020 models, which the company no longer distributes in the U.K., will stop delivering insulin at the start of 2016 and will generate a "call service alarm," according to the U.K.’s Medicines & Healthcare products Regulatory Agency.
The insulin pumps should operate as normal until January 1, 2016, Animas assured regulators. Company representatives did not immediately respond to requests for comment.
Animas began in November 2012 to warn patients of the impending malfunction, offering to replace devices that have warranties that will still be in effect when the software glitch is expected to hit.
"We are also committed to providing assistance to our patients whose warranties will expire prior to Dec. 31, 2015," according to the warning letter. "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."
The device warning has also been sent to healthcare regulators in Northern Ireland, Scotland and Wales, according to the MHRA alert.