MiniMed Reports Problems with Paradigm QuickSet Plus
The following message was received from Deanne McLaughlin, Communications Manager, Medtronic MiniMed on March 10, 2004:
Since the commercial release of the Quick-set Plus infusion set in late November 2003, we have registered an increased number of complaints from customers using this product. While many of our customers are using this infusion set successfully, some customers have reported difficulties, which have occasionally resulted in the interruption of insulin delivery and elevated blood sugar levels. We are disappointed that this product has caused difficulties for any of our customers, as our goal is always to improve the health and quality of life of those we serve. As a result, Medtronic MiniMed and its infusion set supplier have initiated design enhancements, including an improved adhesive and a stronger cannula.
We, through our supplier, have voluntarily notified the FDA of an increased number of complaints received for Quick-set Plus and are in the process of notifying patients, healthcare professionals and distributors. To help customers, we are mailing them a Quick-set Plus Tips Guide, which is also available on our website at www.minimed.com.
For patients experiencing difficulty with the set, our 24-Hour Help Line (1-800-MINIMED or 800-646-4633) is available to provide additional training and alternate infusion set choices until the improved Quickset Plus becomes available. Customers can review detailed information about alternate infusion sets at www.minimed.com/QSP. We expect to have a resolution for customers who have experienced difficulty with Quick-set Plus in approximately 2-3 months, and truly apologize for any inconvenience this may cause.
For additional information see the Customer Letter Regarding the Paradigm QuickSet Plus.
Source: E-mail from Medtronic MiniMed Communications Manager
March 10, 2004
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