Events

Recall of Fine Tuning Your Pump'' booklet provided with Model MMT-515 AND MMT-715 INSULIN INFUSION PUMPS

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic MiniMed.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    33025
  • Event Risk Class
    Class 3
  • Event Number
    Z-0162-06
  • Event Initiated Date
    2005-04-27
  • Event Date Posted
    2005-11-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-03-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41220
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Pump, Infusion, Insulin - Product Code LZG
  • Reason
    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.
  • 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.

Device

Fine Tuning Your Pump'' booklet provided with Model MMT-515 AND MMT-715 INSULIN INFUSION PUMPS
  • Model / Serial
    All Models MMT-515 and MMT-715 shipped between 10/01/2004 and 04/05/2005
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Bahamas, Bermuda, Canada, Mexico, and Puerto Rico.
  • Product Description
    Fine Tuning Your Pump'' booklet provided with Model MMT-515 AND MMT-715 INSULIN INFUSION PUMPS
  • Manufacturer
    Medtronic MiniMed

Manufacturer

Medtronic MiniMed
  • Manufacturer Address
    Medtronic MiniMed, 18000 Devonshire St, Northridge CA 91325-1219
  • Source
    USFDA