Class 3 Device Recall

• Date Initiated by Firm: April 27, 2005
• Date Posted: November 18, 2005
• Recall Status: Terminated on March 20, 2007
• Recall Number: Z-0162-06
• Recall Event ID: 33025
• Product Classification: Pump, Infusion, Insulin - Product Code LZG
• Product: ''Fine Tuning Your Pump'' booklet provided with Model MMT-515 AND MMT-715 INSULIN INFUSION PUMPS
• Code Information: All Models MMT-515 and MMT-715 shipped between 10/01/2004 and 04/05/2005
• Recalling Firm/ Manufacturer: Medtronic MiniMed; 18000 Devonshire St; Northridge CA 91325-1219
• Manufacturer Reason for Recall: The text description of how to perform insulin sensitivity testing and associated worksheet included in the booklet that is shipped with the Paradigm 515 and Paradigm 715 insulin pumps contained a basic flaw in that the blood glucose after the correction should be compared to the target glucose and it says compare to the beginning blood glucose in the procedure.
• FDA Determined Cause: Other
• Action: All end users who recieved the model MMT-515 or MMT-715 pump that included the 'Fine Yuning Your Pump' workbook will be notified through a letter.
• Quantity in Commerce: Approximately 14,560
• Distribution: Nationwide, Bahamas, Bermuda, Canada, Mexico, and Puerto Rico.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.