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Our records indicate that you may be using a Tandem Diabetes Care insulin pump. Because your safety is our top priority, we are alerting you of a potential safety risk.

At Tandem Diabetes Care, patient safety is our top priority, and we are committed to delivering safe and effective therapies of the highest possible quality and reliability. We appreciate your time and attention in reading this important notification.

 
 

 
 

Issue Description:

Insulin pumps from Tandem Diabetes Care include a Personal Profile that allows the user to personalize the settings that define the delivery of basal and bolus insulin within specific time segments throughout a 24-hour period. It is important that the user correctly inputs Personal Profile settings when creating or editing a Personal Profile segment. Inputting incorrect values in a user’s Personal Profile can lead to under delivery or over delivery of insulin, which could result in hyperglycemia or hypoglycemia.

As outlined in the User Guide that you received with your Tandem pump, your pump displays a “Confirm Settings” screen where you confirm that your basal rate change was correctly entered.

This issue may affect users on all Tandem insulin pumps.

Confirm Settings Screen

Personal Profile Confirm Setttings Screen

 
 

 
 

Precautions Recommended for all Patients:

Extra caution should be taken when creating or editing a profile within your Tandem insulin pump to ensure that all entered values are correct. Patients should double check that they correctly input all values before advancing past the Confirm Settings screen.

At Tandem Diabetes Care, patient safety is our top priority, and we are committed to delivering safe and effective therapies of the highest possible quality and reliability. We appreciate your time and attention in reading this important notification.