A Medical Device Daily
Animas (West Chester, Pennsylvania), a manufacturer of insulin pumps, said that it would be recalling about 2,000 of the newly released IR 1250 pumps, due to a recently identified software "bug" related to use of the food database.
The company said that use of the device's food database could cause, in very specific circumstances, a malfunction of certain status field readings or a failure to alarm if this malfunction were to occur.
"All IR 1250 pumps are affected by this software bug," Animas said in a statement. It added that this "bug" does not affect the IR 1200 pump.
Animas said it would take a 3Q05 charge of $300,000 to cover the cost of the recall.
It said the problem was identified following a complaint from a customer regarding use of the food database. It said there have been no reported adverse events as a result, but it noted a "remote possibility" of a hyperglycemic event if an "unlikely set of factors were to arise."
All other pump functions, except use of the food database, operate in accordance with the user guide, it said, and can continue to be used safely, "with assurance, and no loss of functionality, except for use of the food database, so long as they heed the directions outlined in the notification sent to them."
The company said it has contacted patients, healthcare providers and distributors about the recall and provided updated user information.
Kathy Crothall, president and CEO of Animas, said that though there have been no adverse events reported, the recall was being done "in the interest of patient safety."
The company is developing a fix to the software problem; it said it expects to ship replacement pumps with the updated software beginning April 25 and that it will be able to replace all IR 1250 pumps with the new software by early June.
As a result of the 3Q05 charge, Animas is increasing its guidance of net loss, exclusive of in-process R&D charges associated with its acquisition of Cygnus (Redwood City, California), from its prior guidance of a loss of $0.4 million to $0.9 million to a loss of $0.6 to $1.1 million. It also reaffirmed its prior guidance for the year of net revenues between $82 million and $84 million and net income between $3 million and $4 million.