IMPORTANT MEDICAL DEVICE SAFETY INFORMATION
MiniMed™ Silhouette™ and MiniMed™ Sure-T™ tubing detachment
November 2014
Medtronic is committed to keeping our customers informed of issues and solutions concerning our products and services. That is why, in November 2014, we began contacting all of our customers who use MiniMed Silhouette and MiniMed Sure-T infusion sets and their healthcare providers about a potential safety issue with these infusion sets.
As part of our global quality monitoring process, we identified an increase in reports of the tubing becoming detached at the connect/disconnect location on the MiniMed Silhouette and MiniMed Sure-T infusion sets (please see images below). While the number of these reports remains low, you are being notified of this potential issue because your safety is our top priority.
If tubing detachment occurs, insulin delivery is interrupted and the pump will not alarm to notify you. The interruption of insulin delivery can cause hyperglycemia, 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. Seek medical attention immediately if you are experiencing any of these symptoms.
Example of Tubing Detachment
What action do I need to take?
You can continue to use your infusion sets by following the advice below:
- When changing your 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.
- As always, it is essential to monitor your blood sugar levels frequently using your blood glucose meter. Proactively check your tubing connections occasionally throughout the day to ensure tubing is secure. It is especially important to check your blood sugar and tubing connections at bedtime to confirm insulin delivery is occurring.
- If you experience a high blood sugar, check your tubing connections and infusion site closely to ensure your tubing is secure.
If you discover the tubing is detached:
- Do not attempt to reattach the tubing. Replace the infusion set immediately.
- Treat any high blood sugar based on guidelines provided by your healthcare professional.
- Call the Medtronic 24-Hour Helpline at 866.222.7304 to report the issue. We will give you instructions on how to return the affected infusion set to us.
We have identified a solution and are working to incorporate improvements within the coming weeks. In the meantime, you will still be able to order these infusion sets. If you would like to try another type of infusion set instead, we can exchange your infusion sets with the MiniMed Mio® or MiniMed Quick-set® infusion sets.
Information about your other infusion set options
MiniMed Quick-set® Infusion Set
The MiniMed Quick-set infusion set is a 90-degree, soft cannula infusion set and our most popular infusion set. The Quick-serter® insertion tool may be used to easily and comfortably insert the cannula under your skin.
The MiniMed Quick-set infusion set is available in four tubing lengths and two cannula lengths. The 6mm length cannula is most suitable for lean individuals and is available in 18", 23", 32", and 43" lengths. The 9mm cannula is recommended for everyone else and is available in 23", 32", and 43" lengths.
Download a MiniMed Quick-Set infusion set reference guide here.
MiniMed Mio® Infusion Set
The Mio infusion set is an all-in-one design, combining the infusion set and insertion device into one unit. This 90-degree, soft cannula infusion set is available in a variety of colors.
The MiniMed Mio infusion set is available in both a 6mm and 9mm cannula lengths. The 6mm cannula is available in 18", 23" and 32" tubing lengths. The 9mm cannula is available with a 32" tubing.
Download a MiniMed Mio infusion set reference guide here.
For a more detailed chart comparing all four of our MiniMed infusion sets, please visit https://www.medtronicdiabetes.com/customer-support/infusion-set-support/compare-set
Previous Important Notices
Insulin Delivery Programming Through Main Menu, 7/24/14
Important safety information for Medtronic Insulin Pumps
Frequently asked questions
We understand that communications like this can be concerning. However, your safety is our number one priority, so it is important for us to keep you informed of potential issues so you know what to do. In this case, we’re making you aware of a potential safety issue regarding the tubing becoming detached at the connect/disconnect location on the MiniMed Silhouette and MiniMed Sure-T infusion sets.
We have identified a solution and are working to incorporate improvements within the coming weeks. In the meantime, you can continue to use your MiniMed Silhouette and MiniMed Sure-T infusion sets and follow the User Guide and the recommendations provided in the letter. Alternatively, you can exchnage your affected infusion sets for either MiniMed Quick-set or MiniMed Mio infusion sets.
If you discover the tubing is detached:
- Do not attempt to reattach the tubing. Replace the infusion set immediately.
- Treat any high blood sugar based on guidelines provided by your healthcare professional.
- Call the Medtronic 24-Hour HelpLine at 866.222.7304 to report the issue. We will give you instructions on how to return the affected infusion set to us.
We have identified an increase in reports of the tubing becoming detached at the connect/disconnect location on the MiniMed Silhouette and MiniMed Sure-T infusion sets (please see images below).
Example of Tubing Detachment
Yes. Your infusion set is safe to use when following the advice in the User Guide and this letter.
- When changing your 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.
- As always, it is essential to monitor your blood sugar levels frequently using your blood glucose meter. Proactively check your tubing connections occasionally throughout the day to ensure tubing is secure. It is especially important to check your blood sugar and tubing connections at bedtime to confirm insulin delivery is occurring.
- If you experience a high blood sugar, check your tubing connections and infusion site closely to ensure your tubing is secure.
If you discover the tubing is detached:
- Do not attempt to reattach the tubing. Replace the infusion set immediately.
- Treat any high blood sugar based on guidelines provided by your healthcare professional.
- Call the Medtronic 24-Hour HelpLine at 866.222.7304 to report the issue. We will give you instructions on how to return the affected infusion set to us.
However, if you would like to try another type of infusion set, we can exchange your infusion sets with the MiniMed Quick-set infusion set or MiniMed Mio infusion set.
No. You can continue to use your infusion sets as long as you follow the User Guide and this advice.
- When changing your 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.
- As always, it is essential to monitor your blood sugar levels frequently using your blood glucose meter. Proactively check your tubing connections occasionally throughout the day to ensure tubing is secure. It is especially important to check your blood sugar and tubing connections at bedtime to confirm insulin delivery is occurring.
- If you experience a high blood sugar, check your tubing connections and infusion site closely to ensure your tubing is secure.
If you discover the tubing is detached:
- Do not attempt to reattach the tubing. Replace the infusion set immediately.
- Treat any high blood sugar based on guidelines provided by your healthcare professional.
- Call the Medtronic 24-Hour HelpLine at 866.222.7304 to report the issue. We will give you instructions on how to return the affected infusion set to us.
However, if you would like to try another type of infusion set, we can exchange your infusion sets with the MiniMed Quick-set infusion set or MiniMed Mio infusion set.
Yes. This communication is related to all MiniMed Silhouette and MiniMed Sure-T infusion set models sold after June 1, 2013.
- MiniMed Silhouette: MMT-368, MMT-368T, MMT-371, MMT-371T, MMT-373, MMT-373T, MMT-377, MMT-377T, MMT-378, MMT-378T, MMT-381, MMT-381T, MMT-382, MMT-382T, MMT-MMT-383, MMT-383T, MMT-384, and MMT-384T infusion sets.
- MiniMed Sure-T: MMT-862, MMT-862T, MMT-863, MMT-864, MMT-864T, MMT-865, MMT-866, MMT-866T, MMT-873, MMT-874, MMT-874T, MMT-875, MMT-876, MMT-876T, MMT-883, MMT-884, MMT-885, MMT-886, and MMT-886T infusion sets.
No. If you discover the tubing is detached:
- Do not attempt to reattach the tubing. Replace the infusion set immediately.
- Treat any high blood sugar based on guidelines provided by your healthcare professional.
- Call the Medtronic 24-Hour HelpLine at 866.222.7304 to report the issue. We will give you instructions on how to return the affected infusion set to us.
At this time, Medtronic is not replacing product and you can continue using these infusion sets while following the advice in the User Guide and the letter. In addition, you will still be able to order MiniMed Silhouette and MiniMed Sure-T infusion sets. However, if you would like to try another type of infusion set, we can exchange your infusion sets with the MiniMed Quick-set infusion set or MiniMed Mio infusion set.
To learn more about the MiniMed Quick-set and MiniMed Mio infusion sets, you can download this infusion set comparison chart or call our Supply Management Team at 1-800-646-4633,ext 21063.