Jen, thank you Carol
--- jennno@... wrote:

> FYI - in case you have the Ping.
>
>
> -------------- Forwarded Message: --------------
> From: "U.S. Food & Drug Administration (FDA)"
> <fda@...>
> To: jennno@...
> Subject: MedWatch - Animas Insulin Pumps: Battery
> Caps - Class 1 recall due to inadvertent device
> resetting, risk of hyperglycemia
> Date: Fri, 21 Nov 2008 22:25:34 +0000
> > MedWatch logo MedWatch - The FDA Safety
> Information and Adverse Event Reporting
> > Program
> >
> > *Animas Corporation Battery Caps Used with
> the OneTouch Ping System,
> > Animas 2020 Insulin Pump, Animas IR1200 Insulin
> Pump, and Animas IR1250 Insulin
> > Pump* *Audience: *Consumers,
> endocrinological healthcare professionals
> > Animas Corporation and FDA informed
> consumers and healthcare professionals
> > of a nationwide recall of battery caps used with
> the OneTouch Ping System,
> > Animas 2020 Insulin Pump, Animas IR1200 Insulin
> Pump, and Animas IR1250 Insulin
> > Pump. The battery caps used with the above
> infusion pumps were manufactured from
> > June 1, 2008 through July 31, 2008, and were
> distributed from June 16, 2008
> > through August 1, 2008.
> >
> > There may be an intermittent loss of contact
> between the battery cap and the
> > battery compartment in the pump which may result
> in the device resetting. This
> > can cause the device to stop administering
> insulin, which could result in an
> > excess level of glucose in the blood
> (hyperglycemia). Additionally, this failure
> > may lead to user confusion in the amount of
> insulin administered, contributing
> > to errors in future doses, which may result in
> lower than normal level of
> > glucose in the blood (hypoglycemia). Healthcare
> professionals are advised to
> > ensure that their patients replace the battery cap
> on their insulin pump.
> >
> > Read the complete MedWatch 2008 Safety summary,
> including a link to the Class 1
> > Recall Notice, at:
> >
> >
>
http://www.fda.gov/medwatch/safety/2008/safety08.htm#batterycap
>
> >
> >
>
________________________________________________________________________
> >
> > Update your subscriptions, modify your e-mail
> address, or stop subscriptions at
> > any time on your Subscriber Preferences Page [
> >
>
https://service.govdelivery.com/service/user.html?code=USFDA
> ]. You will need to
> > use your e-mail address to log in. If you have
> questions or problems with the
> > subscription service, please contact
> support@....
> >
> > This service is provided to you at no charge by
> U.S. Food & Drug Administration
> > (FDA) [ http://www.fda.gov/ ].
> >
> > FDA [ http://www.fda.gov/ ] HHS [
> http://www.hhs.gov/ ]
> >
> > GovDelivery, Inc. sending on behalf of U.S. Food &
> Drug Administration (FDA) .
> 5600 Fishers Lane . Rockville MD 20857 .
> 800-439-1420
>
> > From: "U.S. Food & Drug Administration (FDA)"
> <fda@...>
> To: jennno@...
> Subject: MedWatch - Animas Insulin Pumps:
> Battery Caps - Class 1 recall due to inadvertent
> device resetting, risk of hyperglycemia
> Date: Fri, 21 Nov 2008 22:25:34 +0000
>
> MedWatch logo MedWatch - The FDA Safety Information
> and Adverse Event Reporting Program
>
> *Animas Corporation Battery Caps Used with the
> OneTouch Ping System, Animas 2020 Insulin Pump,
> Animas IR1200 Insulin Pump, and Animas IR1250
> Insulin Pump* *Audience: *Consumers,
> endocrinological healthcare professionals
> Animas Corporation and FDA informed consumers
> and healthcare professionals of a nationwide recall
> of battery caps used with the OneTouch Ping System,
> Animas 2020 Insulin Pump, Animas IR1200 Insulin
> Pump, and Animas IR1250 Insulin Pump. The battery
> caps used with the above infusion pumps were
> manufactured from June 1, 2008 through July 31,
> 2008, and were distributed from June 16, 2008
> through August 1, 2008.
>
> There may be an intermittent loss of contact between
> the battery cap and the battery compartment in the
> pump which may result in the device resetting. This
> can cause the device to stop administering insulin,
> which could result in an excess level of glucose in
> the blood (hyperglycemia). Additionally, this
> failure may lead to user confusion in the amount of
> insulin administered, contributing to errors in
> future doses, which may result in lower than normal
> level of glucose in the blood (hypoglycemia).
> Healthcare professionals are advised to ensure that
> their patients replace the battery cap on their
> insulin pump.
>
> Read the complete MedWatch 2008 Safety summary,
> including a link to the Class 1 Recall Notice, at:
>
>
http://www.fda.gov/medwatch/safety/2008/safety08.htm#batterycap
>
>
>
________________________________________________________________________
>
> Update your subscriptions, modify your e-mail
> address, or stop subscriptions at any time on your
> Subscriber Preferences Page [
>
https://service.govdelivery.com/service/user.html?code=USFDA
> ]. You will need to use your e-mail address to log
> in. If you have questions or problems with the
> subscription service, please contact
> support@....
>
> This service is provided to you at no charge by U.S.
> Food & Drug Administration (FDA) [
> http://www.fda.gov/ ].
>
> FDA [ http://www.fda.gov/ ] HHS [
> http://www.hhs.gov/ ]
>
> GovDelivery, Inc. sending on behalf of U.S. Food &
> Drug Administration (FDA) . 5600 Fishers Lane .
> Rockville MD 20857 . 800-439-1420


Carol Dunn