Breaking: Recall and Medical Device Correction

February 17, 2020

We want to keep our CWD family up-to-date on the latest in research and technology developments, including issues and recalls. In the last week, Medtronic has recalled certain insulin pumps, and Insulet issued a medical device correction.

The Medtronic recall, according to the FDA write-up, includes the following pumps:

Recalled Product

    • MiniMed 600 Series Insulin Pumps
    • Model 630G (MMT-1715) – all lots before October 2019
    • Model 670G (MMT-1780) – all lots before August 2019

Distribution Dates:

    • Model 630G – September 2016 to October 2019
    • Model 670G – June 2017 to August 2019

Devices Recalled in the U.S.: 322,005
Date Initiated by Firm: November 21, 2019

You can read the recall here: Medtronic Recalls MiniMed Insulin Pumps for Incorrect Insulin Dosing

The Insulet medical device correction states:

“As part of our ongoing quality monitoring processes, we have identified that on rare occasions, the Omnipod DASH PDM may suggest an inaccurate bolus amount based on a blood glucose value that is more than 10 minutes old when the user does not exit the bolus calculator as designed or when a system alarm interrupts a bolus calculation. If the user delivers the bolus, this may result in over or under delivery of insulin which may lead to hypoglycemia or hyperglycemia. No injuries have been reported as a result of this potential issue and the Omnipod DASH System is safe for continued use and distribution.”

You can read about the medical device correction here: Insulet Issues Medical Device Correction Regarding its Omnipod DASH™ Insulin Management System

Stay informed, and stay safe, CWD friends.