Medtronic Issues Urgent Basal Insulin Reminder for Pump Users
By Arvind Sommi
If you are a new or existing user of Medtronic's MiniMed pumps, read more about what immediate steps you need to take to avoid serious injuries.
Medtronic is sending out a letter this week to everyone who received one of its new or replacement insulin pumps within the last six months to remind them to make sure they have saved their basal insulin rates on their devices.
The “urgent medical device correction” notice was prompted by a series of injuries recently due to the use of pumps that had not been properly programmed. Medtronic is one of the world’s largest insulin pump manufacturers with over 250,000 users.
Pamela Reese, director of communications at Medtronic, advised that customers need to be aware that Medtronic’s insulin pumps do not arrive pre-programmed with their basal insulin rates.
“Take a moment to read those notifications, we are sending them because patient safety is incredibly important,” said Reese. The notification’s purpose, she said, is to remind users to manually enter and save this information to complete the pump’s setup.
The company began notifying doctors last week and beginning Feb. 1, it will notify all those who have received a MiniMed 600 series or MiniMed 700 series insulin pump in the last six months. Reese said the company plans to notify customers by email in batches throughout the week and will send a letter by mail to those it can’t reach by email.
As a reminder, basal insulin provides a constant level of insulin throughout the day and helps you sufficiently manage your blood glucose when you’re not eating. For this reason, basal insulin is sometimes referred to as “background” insulin.
An insulin pump can deliver insulin to your body throughout the day without the need for manual injections. When connected with a continuous glucose monitor (CGM), an insulin pump can increase or decrease your insulin dose as needed in response to your blood sugar levels. To learn more, visit our page, “Automated Insulin Delivery.”
What are the risks?
Basal insulin delivery can be crucial to managing glucose levels. Although instructions are provided with the MiniMed insulin pumps, cases have been reported of users not properly setting up their basal insulin rates prior to use, Reese said.
Reese said that there were two primary reasons why these basal insulin rates were missing. There may have been some misunderstanding when someone received a new or replacement pump when “they didn’t realize they needed to put those settings into it, so they were just at zero.”
Additionally, there may have been confusion among those entering the data since “within the menu, there are a couple of clicks, there is ‘done’ and ‘save’ and you actually have to hit both of them to make sure that those are properly saved in the pump,” she said.
“The pump is never going to just start delivering insulin without being told how much insulin to deliver,” she said.
This potential under-delivery of basal insulin puts users at risk for severe hyperglycemia and life-threatening diabetic ketoacidosis (DKA). According to the Medtronic letter, “Serious injuries have been reported with the use of the MiniMed™ 600 series and MiniMed™ 700 series insulin pumps which may be directly attributed to not setting basal rates.”
In addition, the company said in the letter, “One death has been reported, although a review by independent clinical experts did not directly attribute this to not setting basal rates.”
If you are on any kind of Medtronic insulin pump, “it would be really smart to make sure that you write down what some of your key settings are, like your basal rate,” Reese said. “If you do need to get a new pump, or you have been playing with the pump and accidentally cleared something out, you’re going to want to be able to put those back in.”
How to set up your basal insulin rate on a Medtronic pump
If you are a new user and/or using a new replaced device:
Do not use your pump until you have consulted with your healthcare professional to determine your insulin settings.
Once you confirm which settings to use, navigate to the “Options” menu on your MiniMed pump and click on “Delivery Settings” to enter your basal insulin information. Check your device’s specific user manual to confirm how to access this page.
Once you have entered your basal insulin settings, you must scroll down and select “Done” on the first page, and then select “Save” on the next screen. If done successfully, you will receive a confirmation with the text “Changes saved” and a checkmark. Medtronic provided the following example of how this may appear:
Once you confirm your basal insulin rates, you can complete the confirmation form that Medtronic provided. Submitting this confirmation form lets Medtronic know that you have received and read their safety notification.
If you are an existing user:
Verify your current basal rate settings by clicking on “Basal” and then “Basal Patterns.” If these basal rates are correct, then you can skip the remaining steps and complete the confirmation form that Medtronic provided.
If you are unable to locate your basal rate settings on your device, you could check if they have been uploaded to your CareLink account in the past 90 days. As mentioned in the Medtronic notification, you can “log into your CareLink Personal, navigate to ‘Reports’, then ‘Select custom range’ to choose a week that had the previous pump’s upload, select ‘DEVICE SETTINGS SNAPSHOT’, and select ‘Generate reports’. The settings should have a non-zero basal rate.”
If you are unable to find your basal rate settings or have further questions, please consult with your healthcare provider. You may need to enter your basal rate settings as described above.
Reese said that if Medtronic does not receive an acknowledgment form from you that you received and read the notice, they will either send another email or send a physical letter to you. “We will make multiple attempts to make sure someone actually saw it and paid attention to the letter,” she said. Once you complete the acknowledgment form, you will no longer receive follow-up emails.
If you encounter any difficulties, please contact Medtronic’s 24-hour technical support line at 1-800-646-4633. If you have any questions regarding your basal insulin rate, please contact your healthcare provider.
Is this related to the recent Medtronic product recalls?
This notification is not associated with the recent Medtronic recall of their 600 series insulin pumps. While this notification focuses on making sure users properly set up their basal insulin rate on their insulin pump, the previous recall was due to damaged retainer rings. Your device will not need to be replaced because of the current notification.
Moving forward, Reese said that Medtronic will look into making their pump menus more user-friendly and updating the educational materials that come with the box to be more clear.