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Insulin Pump Users Notified of Software Bug
Insulin Pump Users Notified of Software Bug -- Posted by Gumbo on 10-29-04 05:08
Insulin Pump Users Notified of Software Bug
Animas Corporation (PUMP), a manufacturer of insulin pumps, announced that
it will be notifying patients using the IR 1200 pump and their healthcare
providers that, as a result of a recently-identified software bug, the
operation of the pump as described in the IR 1200 User Guide differs from
its actual operation when a patient suspends insulin delivery.
All other pump functions operate in accordance with the User Guide.
The User Guide states that when a patient suspends insulin delivery, the
pump will provide an audible, vibrational and visual reminder that delivery
has been halted. As a result of the software bug, the pump, in certain
circumstances, provides only a visual reminder.
The company confirms that patients can continue to use their pump safely,
with assurance and no loss of functionality, so long as they are aware they
may receive only the visual reminder in the suspend mode, as opposed to
audible, vibrational and visual reminders.
Animas will formally contact patients, healthcare providers and distributors
of this software bug and provide updated user information. The company has
also set up a special Help Line to handle customer inquiries. All IR 1200
pumps shipped between April 15, 2004, and September 25, 2004, are affected
by this software bug.
"We are sorry for any inconvenience this software bug may cause our
customers," said Kathy Crothall, president and CEO of Animas Corporation.
"Animas is very committed to patient safety and product quality, and as
such, we are taking the appropriately proactive steps to assure such
safety."
The company has corrected the software and all IR 1200 pumps shipped after
September 26, 2004, contain the corrected software.
Animas reaffirmed its prior guidance for the third quarter of approximately
$20-21 million for net revenue and $2.0-$3.0 million for net income, and for
the year of approximately $60-$62 million for net revenue and a net
operating loss between $1 and $2 million.
The company expects that the cost associated with this software bug and
corrective action will be approximately $150,000, a charge to be taken in
the third quarter. This article was prepared by Biotech Law Weekly editors
from staff and other reports. Copyright 2004, Biotech Law Weekly via
LawRx.com.
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