Insulin Pump Recalls

- Mei 29, 2017

FDA Issues a Recall on OmniPod Insulin Management System ...
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Animas Corporation is an American company that specializes in making insulin pumps, used by people with diabetes. The company was founded by Dr. Katherine Crothall in 1996, had its initial public offering in May 2004 under the ticker symbol 'PUMP', and was ultimately acquired by Johnson & Johnson on February 18, 2006. The business is headquartered in West Chester, Pennsylvania and forms part of the Johnson & Johnson Diabetes franchise along with Lifescan and several other companies producing medical products for the treatment and management of diabetes.


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Animas 2020

The Animas 2020 is an insulin pump that carries 200 units of insulin and can be connected to an infusion set following the Luer standard. Its predecessor was the Animas IR1250.

The pump comes in five different colors, features a color screen and allows the user to have custom alarm tones. To improve treatment the system can save instructions to use when its user has a sick day and up to 500 rules set by the user on how to act on different occasions (such as when eating a certain food type).

In April 2013, the Food and Drug Administration issued a Class I Recall for the Animas 2020. The recall specifies an issue with the pump initiating a false alarm or warning sound, which may prompt pump users to inadvertently administer more insulin and can result in a serious health risk.


FDA Issues a Recall on OmniPod Insulin Management System ...
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Animas Ping

The Animas Ping is an insulin pump which communicates wirelessly with a meter/display device.


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Animas Vibe

Animas Corporation teamed up with Dexcom Inc. and developed the first insulin pump integrated with continuous glucose monitoring (CGM), called the Animas Vibe.

With the Animas Vibe, users can view their historical and latest glucose readings on the screen of the insulin pump, which points out highs and lows of blood glucose, better allowing users more accurate and relevant information in administering their insulin doses. Again, The imbedded CGM technology shows real-time glucose levels on a color graph and measures level trends by automatically taking blood glucose levels every five minutes. The Animas Vibe includes a delivery system with basal rate increments as low as 0.025 U/hr, bolus ranges from 0.05 U to 35 U, colored CGM with a 13% Mean Absolute Relative Difference (ARD), is waterproof to 12 feet for 24 hours (pump), and has customizable alarms for detecting high and low glucose levels.

In June 2014, the Animas Vibe revealed promising data through a Juvenile Diabetes Research Foundation collaborative study where twelve study participants maintained minimum exposure of hypoglycemic blood glucose levels, deemed at glucose <70 mg/dL, for 99.1% of the study duration. This success was made possible by the integration of Animas' predictive hypoglycemia-minimizing algorithm and Dexcom's G4 PLATINUM CGM. The Animas Vibe varied in insulin dosing response dependent upon an "aggressiveness factor".

In November 2014, the FDA approved the Animas Vibe for managing insulin-required diabetes in adults, and Animas anticipates shipping the device to customers by January 2015. The development and subsequent FDA approval of the Animas Vibe brings the industry one step closer to bringing a viable artificial pancreas to market.

Source of the article : Wikipedia



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