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URGENT: MEDICAL DEVICE NOTIFICATION

March 19, 2010

Important Information about the OneTouch® Ping® Glucose Management System, the Animas® 2020 Insulin Pump, and the Animas® IR 1200 Insulin Pump

Dear Animas Pumper:

Animas is dedicated to supporting pumpers with quality customer service and products. As part of that commitment, we reach out whenever we have urgent information about our products.

We have learned of several cases in which pumpers have accidentally delivered excessive insulin when they ignored pump warnings and did not disconnect from their infusion set before loading the pump cartridge. In each of these cases, the pump had been damaged. Because of this damage, the pump delivered the whole cartridge of insulin during the "load cartridge" step of the priming sequence.

Failure to follow safety instructions and disconnect your infusion set from your body during the "rewind, load and prime" steps can lead to unintended delivery of insulin. This can cause serious injury or death.

This warning is in your Owner's Booklet or User Guide and was part of your pump training. The pump also warns you to disconnect before these steps (see below). NEVER IGNORE THESE WARNINGS.

Illustration

There is NO SAFETY RISK from this condition if you ALWAYS disconnect your infusion set from your body when:

  • rewinding the motor
  • loading the cartridge
  • priming the infusion set tubing
  • tightening the cartridge cap

Please note, this issue does NOT occur during basal and bolus insulin delivery.

 

How Will I Know if My Pump is Affected?

  • If you see a pump warning message that says: “No Cartridge Detected. Delivery Disabled” after the “Load Cartridge” step; or
  • If you see repeated “no prime” warnings (see below) that are not related to an occlusion alarm, auto-off alarm or loose cartridge cap; or
  • Illustration
  • In some cases, you may also notice that the pump’s screen is hard to read or goes blank.

If you notice any of these things, contact Animas Customer Support at 1-866-949-1526 or call the toll free number on the back of the pump. As always, if you need immediate medical attention call your healthcare provider or 911.

 

What do I do now?

The key things to remember are:

  • Follow your Owner’s Booklet or User Guide instructions;
  • Pay attention to all pump warnings; and
  • NEVER rewind the pump motor, load the insulin cartridge, or prime your infusion set while connected.

Should you have any questions or concerns, please call the Animas Customer Support Department. A trained healthcare professional will take your call at 1-866-949-1526 or you can call the toll free number on the back of your pump at 1-877-937-7867. If you are travelling outside of the U.S. or Canada, please call 610-644-8990, option 1.

 

We have also sent a letter to your healthcare provider to inform them of this issue.

 

Sincerely,

Animas Corporation