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Friday, November 14, 2014

INFUSION SET SAFETY NOTIFICATION Select Lots of Unomedical Infusion Sets Comfort™, Comfort™ Short and Contact™ Detach

INFUSION SET SAFETY NOTIFICATION
Select Lots of Unomedical Infusion Sets
Comfort™, Comfort™ Short and Contact™ Detach
November 13, 2014
Dear ******,
Unomedical, a manufacturer of infusion sets used by a number of insulin pump companies, has recently contacted us about a potential safety issue regarding their Comfort™, Comfort™ Short and Contact™ Detach infusion sets. 
Unomedical states that there have been reports of the tubing becoming detached at the connect/disconnect location on these infusion sets (images below). While we are told the number of these reports remains low, we wanted to make our trainers aware of the potential issue and that we have notified all our affected customers.

 
If tubing detachment occurs, insulin delivery is interrupted and the pump will not alarm to notify the user. The interruption of insulin delivery can cause hyperglycemia (high blood sugar), which if left untreated, can result in diabetic ketoacidosis (DKA). DKA is a serious condition that can cause a severe impact to health, including death. Symptoms of DKA may include nausea, vomiting, shortness of breath and excess thirst/urination. We are instructing users to seek immediate medical attention if they experience any of these symptoms.



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.
Sincerely,

Kim Blickenstaff
President & CEO

Comfort/Comfort Short   REF 004172, 004173, 004174, 004177, 004178, 004179
Contact Detach   REF 004182, 004183, 004187, 004188
ML-000257_A

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