What are we instructing users to do?
They can continue using their infusion sets by following the advice below:
1. When changing their infusion set, closely follow the instructions for use included in the product box. Check the tubing at the connect/disconnect location identified in the drawings above to make sure it is not loose.
2. As always, it is essential to monitor your blood sugar levels frequently using your blood glucose meter. Proactively check the tubing connections occasionally throughout the day to ensure tubing is secure. It is especially important to check blood sugar and tubing connections at bedtime to confirm insulin delivery is occurring.
3. If they experience a high blood sugar, check their tubing connections and infusion site closely to ensure the tubing is secure.
If they discover the tubing is detached:
1. Do not attempt to reattach the tubing. Replace the infusion set immediately.
2. Treat any high blood sugar based on guidelines provided by their healthcare professional.
3. Call Tandem’s 24/7 Customer Support at (877) 801-6901 to report the issue.
Unomedical has identified a solution to the problem, which will be implemented in the coming months. In the meantime, if your patients have experienced the detachment issue described above or have concerns about being able to implement the advice in the notification for using Comfort™, Comfort™ Short or Contact™ Detach infusion sets, they can exchange their affected product with the Cleo® 90 or the Inset™ infusion sets. Click here for additional information about this safety notification.
You can report a concern to the FDA’s MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch/HowToReport/), by telephone (800-FDA-1088) or by fax (800-FDA-0178).
We appreciate your time and attention to this important notification, and apologize for any inconvenience. Our customers' safety is our top priority, and we are committed to quickly addressing issues when they arise. Our goal, as always, is to provide superior customer service.
Thank you for being a part of the Tandem family.
President & CEO
Comfort/Comfort Short REF 004172, 004173, 004174, 004177, 004178, 004179
Contact Detach REF 004182, 004183, 004187, 004188