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5. What extra precautions should I take?
Update your t:connect
®
mobile app version as described above. Regularly check your
blood sugar as recommended in your training and user guide to ensure you are not
having unexpectedly high or low readings. Please monitor your pump battery level
closely and always carry back-up supplies.
6. What is a field correction notice?
Correction means repair, modification, adjustment, relabeling, destruction, or
inspection (including patient monitoring) of a product without its physical removal to
some other location according to the FDA. In this instance we are alerting you to a
potential safety risk from using older versions of the t:connect
®
mobile app.
7. Why are you not physically recalling these Tandem Insulin Pumps?
By updating to version 2.7.1 of your t:connect
®
mobile app, this incorporates quality
improvement made to the app software that mitigates the potential issues.
8. What can be the potential risk?
Serious injury might occur if the battery fully depletes resulting in an under-delivery of
insulin, which may result in hyperglycemia. In severe cases of hyperglycemia, the user
may experience diabetic ketoacidosis and may require hospitalization or intervention
from a medical professional.
9. I haven’t had any problems. Do I need to worry about my pump?
Even if you haven’t experienced these issues, ensure your t:connect
®
mobile app has
been updated to the latest mobile app version 2.7.1 as described above.
10. Is there any training required to update to the latest mobile app version?
No training is required to use the new mobile app version.
11. What do I do if I experience an adverse event of quality problem?
If you experience any adverse reactions or quality problems with the use of our
products, please email Techsupport@tandemdiabetes.com or call Tandem Diabetes
Care Customer Technical Support at 1-877-801-6901. Our team is available 24/7/365.
Alternatively, you can also utilize the FDA’s MedWatch Adverse Event Reporting
program either online (www.fda.gov/medwatch/report.htm), by regular mail or by fax
(1-800-332-0178). As always, if you are having a medical emergency, call 911.