Medtronic Loose Drive Support Cap

Medtronic Loose Drive Support Cap

important medical device safety information

Loose Drive Support Cap and Potential for Water Damage, 4/1/13
Important safety information for Paradigm® pumps Download

At Medtronic, we are committed to continuing to improve our products and services to enable people to manage diabetes. We recently sent a letter to notify U.S. Paradigm users and their healthcare professionals of two potential issues relating to Paradigm insulin pumps.

We are informing our customers of the potential for a loose drive support cap. In rare cases, the cap may stick out from the side of the insulin pump as a result of impact(s) with a hard surface. The letter also reminds our customers of the existing User Guide instructions that exposure to water can damage the insulin pump's internal electronics.

We are confident in the reliability of our Paradigm insulin pump platform and its ability to deliver safe and effective therapy for those who need it. Customer safety is our top priority. If you believe your insulin pump has a loose drive support cap, has damage as a result of exposure to water or observe any other possible insulin pump malfunction, please immediately discontinue the use of your insulin pump, and contact us at 1.888.204.7616, Option 1 and 2, for assistance with troubleshooting.

Video
Medtronic MiniMed 530G, 10/7/13
Important safety information for MiniMed 530G®
Medtronic Paradigm Reservoirs, 7/5/13
Important safety information for Paradigm® Reservoirs
Medtronic Paradigm Tubing Connectors, 6/10/13
Important safety information for Paradigm® Tubing Connectors
indented flush protruding side-by-side
indented
Normal drive support cap
Loose drive support cap
Loose drive support cap
Side by side

This is a normal drive support cap, the cap is slightly indented. You can continue to use your insulin pump.

This is a loose drive support cap, the cap is not indented. If the drive support cap is sticking out, as shown in the photo above, do not press on this portion of the pump. Please discontinue use of the insulin pump and contact Medtronic at 1.888.204.7616, option 1, to arrange for the insulin pump to be replaced.

This is a loose drive support cap, the cap is not indented. If the drive support cap is sticking out, as shown in the photo above, do not press on this portion of the pump. Please discontinue use of the insulin pump and contact Medtronic at 1.888.204.7616, option 1, to arrange for the insulin pump to be replaced.

FAQs
Q
I didn’t get a letter from Medtronic, was I supposed to? >
A