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FW: MedWatch - Animas Insulin Pumps: Battery Caps - Class 1 recall   Message List  
Reply | Forward Message #545 of 899 |
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



Fri Nov 21, 2008 11:19 pm

nowakjennifer
Offline Offline
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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. 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).

FDA HHS

GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420



Fri Nov 21, 2008 10:25 pm

fda@...
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Forward
Message #545 of 899 |
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FYI - in case you have the Ping. ... From: "U.S. Food & Drug Administration (FDA)" <fda@...> To: jennno@... Subject: MedWatch -...
jennno@...
nowakjennifer
Offline Send Email
Nov 21, 2008
11:19 pm

Jen, thank you Carol ... http://www.fda.gov/medwatch/safety/2008/safety08.htm#batterycap ... https://service.govdelivery.com/service/user.html?code=USFDA ... ...
carol dunn
cadunn022003
Offline Send Email
Nov 23, 2008
12:32 am
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