Urgent: Field Safety Notification

MiniMed^™ Sure-T^™ infusion set needle break field safety notification

Download important safety information for MiniMed^™ Sure-T^™ infusion sets Download

June 2015

Medtronic is committed to keeping you and your healthcare professional informed of issues and solutions related to our products and services.

As part of Medtronic’s product quality monitoring process, we identified that certain MiniMed^® Sure-T^® infusion sets* had a slight increase of reported cases where the steel needle broke during use. In a small number of these reported cases, the needle break led to hospitalization for the management of glucose levels and/or treatment for removal of the needle. Since then, an improvement in the needle manufacturing was implemented, which has reduced the number of reported cases of needle breaks.

If a needle break 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). If you experience a needle break while the infusion set is inserted, consult your healthcare professional.

How do I know if I have affected product (that does not contain the manufacturing improvement)?

Affected MiniMed Sure-T infusion sets are those with an expiration date on or before April 2019. The expiration date is located next to the hourglass symbol on the box and pouch labels. The date format is year followed by month, ex. YYYY-MM.

Affected product expires on or before April 2019 (2019-04)

If you have affected product and would like it replaced free of charge:

A. Use the online form at http://www.medtronicdiabetes.com/notice1 (fastest method)
OR
B. Call us at 1.866.222.7304

If you decide to use affected product, carefully review the instructions for use included with the product, as well as the following:

Prior to use:

Carefully remove the needle guard before inserting the infusion set. The needle guard should be removed without the use of any twisting or bending of the needle guard.
Do not use the infusion set if the needle is bent or has been damaged.
Do not bend the needle prior to insertion.
Consult your healthcare provider for the proper insertion site.

During use:

As always, it is essential to monitor your blood sugar levels frequently using your blood glucose meter.

After use:

Carefully remove the infusion set after use to avoid twisting or bending on the needle.
Please ensure the needle is present on the used infusion set before discarding it.
Please contact your healthcare provider if you suspect that a needle has broken off and remained under the skin.
Continue to monitor your blood sugar.

As always, please call the Medtronic 24-Hour HelpLine at 1.866.222.7304 with any product concerns. It is through the careful monitoring of customer reports that we are able to identify issues and implement solutions.

You can report a concern to the FDA’s MedWatch Adverse Event Reporting program:

A. Online at: http://www.fda.gov/safety/medwatch/howtoreport/
B. Report by telephone: 1.800.FDA.1088
C. Fax report: 1.800.FDA.0178

Medtronic is committed to delivering high quality products and services. We appreciate your time and attention to this important notification.

*This field notification involves models 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.

Previous Important Notices

MiniMed Silhouette and MiniMed Sure-T Tubing Detachment - 11/2014
Important safety information for Medtronic Insulin Pumps

Frequently asked questions

I received the letter and I am concerned about my infusion set. What do I do?

We understand that communications like this can be concerning. Your safety is our number one priority, so it is important for us to keep you informed of significant information like this. In this case, we’re making you aware of a field safety notification regarding certain MiniMed Sure-T infusion sets. Only those MiniMed Sure-T infusion sets with expiration dates on or before April 2019 are affected.

Those affected infusion sets have been associated with a slight increase of reported cases where the steel needle broke during use. In a small number of these reported cases, the needle break led to hospitalization for the management of glucose levels and/or treatment for removal of the needle. While the occurrence rate was low, an enhancement in the needle manufacturing has since been implemented, which has reduced the number of reported cases of needle breaks.

Check the expiration date on any unused MiniMed Sure-T infusion sets you have in your possession to see if you have any affected product. Click here for instructions.

Have the MiniMed Sure-T infusion sets been fixed?

A change in the manufacturing process was made to enhance the strength and reliability of the infusion set steel needle. Since the change was implemented, we have seen a reduction in the number of reported cases of needle breaks.

How can I tell if the steel needle of my infusion set has broken off?

When you change your infusion set, you should be able to see if the needle is attached or not. We recommend checking your infusion site any time you have unexplained high blood sugar to ensure that the infusion set is secure and that the needle is where it’s supposed to be. A broken steel needle is one of the reasons you can experience high blood sugar.

What should I do if I discover the steel needle from my infusion set has broken off?

If you experience a needle break while the infusion set is inserted, please consult your healthcare professional.

What could happen to me if I experience a needle break?

Is there an alarm on the insulin pump that will notify me if the steel needle breaks?

If needle breakage occurs, insulin delivery is interrupted and the pump will not alarm to notify you. The pump is still pushing insulin from the reservoir into the tubing but it cannot detect a broken steel needle.

Will Medtronic be replacing all MiniMed Sure-T infusion sets currently in the marketplace?

Customers have a choice to either continue using affected product or replace it free of charge.

You can check the expiration date on any unused MiniMed Sure-T infusion sets you have in your possession to see if you have any affected product. Affected product expires on or before April 2019 (2019-04)

If you have affected product and would like it replaced free of charge:

A. Use the online form at http://www.medtronicdiabetes.com/notice1 (fastest method)

B. Call us at 1.866.222.7304

Is this a recall?

No. The infusion set manufacturer is issuing a global field safety notification of certain steel needle infusion sets: MiniMed Sure-T infusion sets and contact™ Detach infusion sets. MiniMed Sure-T models that may be affected: 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.

Only those MiniMed Sure-T infusion sets with expiration dates on or before April 2019 are affected.

If you have affected product and would like it replaced free of charge:

A. Use the online form at http://www.medtronicdiabetes.com/notice1 (fastest method)

B. Call us at 1.866.222.7304

Is my infusion set safe to use?

Yes. Whether you have affected product or not, your Sure-T infusion sets are safe to use, when used in accordance with the instructions for use included with your product, as well as the instructions outlined in the letter.

If you decide to use affected product, we encourage you to carefully review the instructions for use included with your product, as well as following the instructions outlined in the letter. Click here for instructions.