Patient Safety Alert

Veterans Health Administration Warning System 
 
Published by VA Central Office

                                                                    May 19, 2004

Item:   Class I Recall of Medtronic MiniMed Paradigm® Quick-set® Plus Infusion Sets.  
 

Specific Incident: Medtronic MiniMed issued a Class I recall on the Paradigm® Quick-set® Plus Infusion Sets Model MMT-359S6, MMT-359S9, MMT-359L6 and MMT-359L9. Problems with the infusion sets can interrupt insulin flow resulting in serious injury. 
 

Actions: 1.  If you still have any of the above mentioned product in inventory, immediately stop distributing them to your patients.

2. Please complete the enclosed Distributor Response Form indicating how you will proceed with this mandatory notification and return it by fax as soon as possible to the manufacturer.
3. Please also complete the enclosed Exchange Request Form so that arrangements can be made to return all affected product to the manufacturer for disposal and send you the replacement products of your choice.

Additional Information:  See www.minimed.com/QSP for FAQs and customer letters.

Source:     Medtronic MiniMed and FDA. 

Contact:   Cathy Haley at Medtronic MiniMed: (818) 576 5594.

OR

Bryanne Patail at National Center for Patient Safety (NCPS) phone: (734) 930-5890.

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Medtronic Recalls Quick-Set® Plus Infusion Sets

Contact: 
Bob Hanvik (Media) 
(763) 505-2635  
Rachael Scherer (Investors) 
(763) 505-2694

FOR IMMEDIATE RELEASE -- Northridge, CA -- May 18, 2004 -- Medtronic, Inc. today announced that its Diabetes division began notifying diabetic patients, healthcare professionals and distributors that it is conducting a nationwide recall of Quick-set ® Plus infusion sets because of problems that can interrupt insulin flow to diabetics who use them. These problems have resulted in a number of serious injuries, including some hospitalizations. 
 

The company is asking patients to contact its 24-Hour Help Line at (800) MINIMED (1-800-646-4633) to exchange any unused Quick-set Plus infusion sets for replacement sets available currently from Medtronic. In the event that it is necessary to continue use of the Quick-set Plus while replacement sets are in transit, Medtronic is recommending that patients monitor their blood glucose levels frequently and be prepared to treat any elevated glucose levels that may occur with injections. Patients are also being instructed to contact their healthcare professional in the event of excessively high or low glucose levels or with any questions about their care. Information regarding the exchange of Quick-set Plus infusion sets is available at www.minimed.com/QSP.  
 

This recall applies to all Paradigm Quick-Set Plus models (MMT-359S6, MMT-359S9, MMT-359L6 and MMT-359L9) and lot numbers. This action affects only the Quick-set Plus infusion set; no other Medtronic devices or infusion sets are involved in this recall. 
 

This notification is a follow-up to a voluntary action undertaken by the company in March 2004 in response to an increased number of complaints related to the use of the Quick-set Plus infusion set, which delivers insulin from an infusion pump to a patient’s body. The complaints involved problems with bending of the infusion set’s cannula or unintentional disconnection of the set at the insertion site. At that time, customers were provided with a Quick-set Plus tips guide and offered replacement infusion sets upon request. The company also discontinued selling the Quick-set Plus infusion sets in conjunction with this initial notification.

The U.S. Food and Drug Administration (FDA) has classified this voluntary action as a Class I recall. The FDA defines a Class I recall as a situation in which there is a reasonable probability that the use of the product will cause serious adverse health consequences or death.