URGENT FIELD SAFETY NOTIFICATION


MiniMed™ 670G insulin infusion pump - Potential loss of audio issue


Download MiniMed™ 670G Insulin Infusion Pump Potential Loss of Audio Issue – Notification letter Download

We have received reports of occurrences in which the MiniMed™ 670G insulin pump with version 4.10 software has failed to make expected audio sounds during alerts, alarms, or sirens. This failure could either cause the alarm volume to be stuck at a 4 (out of 5) level regardless of your personal setting, or it could make no sound. Either of these occurrences could cause you to miss system notifications, alarms or sirens associated with how the pump is working, and with high and low glucose alerts. You are receiving this letter because our records indicate you may have one of the potentially affected insulin pumps.

Explanation of the Issue
This issue occurs when a specific electronic component in your pump malfunctions; it can result in the loss of all audio, problems adjusting the audio volume, or the loss of only the emergency audio siren. This potential loss of audio could delay your response to the underlying reason for the alert, alarm, or siren, which could then lead to possible health and safety risks such as hypoglycemia or hyperglycemia. If this issue occurs with your pump, the audio cannot be permanently repaired or regained. The only way to permanently regain your audio capabilities is to exchange the affected pump with a replacement. Even if your pump has the audio issue, it will continue to deliver insulin as expected. Loss of the Vibrate feature has not been reported to occur as part of the above audio failure mode. If you have a pump that contains the specific electronic component, and your pump passes the Audio Beep test described below, there is still a chance that your pump may lose its audio capabilities at some future date.

What you should do:

  1. If you have not already done so, enable the Vibrate feature on your pump. Even if the Audio Beep test passes, you should enable the Vibrate feature (in addition to your Audio feature) since it will add an additional notification to any alerts or alarms you may receive on your pump.

    Follow the steps below to enable both the Vibrate and Audio feature on your pump:

    Press to open the Menu, Scroll down to Audio Options
    Set Audio to “On”, set Vibrate to “On" and Save

  2. Perform an Audio Beep test to see if your pump is experiencing this potential issue. This test will identify if your pump audio is working. The steps for this test can be found at the end of this letter or you can also access our website that will guide you through this process at https://www.medtronicdiabetes.com/checkaudio.

    Important note: You should repeat this test periodically to verify the continued audio functionality of your pump.

If your pump fails the beep test, it will not permanently regain its audio capabilities and a replacement will be required in order for you to use the audio features of your pump. There is also the possibility that even if your pump passes the Audio Beep test, it may lose its audio capabilities and fail the Audio Beep test at a future date. If your pump did not pass the beep test, or you have concerns about this issue and would like to start the process for pump replacement, you should contact us through the link below: https://www.medtronicdiabetes.com/checkaudio

Here you will find access to more information, tutorial videos, and answers to frequently asked questions. You can also call our 24-Hour Helpline at 1-888-204-7616 if further assistance is required.

At Medtronic, patient safety is our top priority, and we are committed to delivering safe and effective therapies that undergo rigorous clinical, quality, manufacturing, and regulatory controls for our customers. We appreciate your time and attention in reading this important notification.

As always, we are here to support you. If you have further questions or need assistance, please call our support line at: 1-888-204-7616

As always, we are here to support you. If you have further questions or need assistance, please call our support line at: 1-888-204-7616.


Sincerely

James Dabbs
Vice President, Quality Assurance
Medtronic Diabetes


AUDIO BEEP TEST
Step MiniMed™ 670G Insulin pump
1 Press to open the Menu screen
2

Select Audio Options
3

Ensure Audio and Vibrate is set to “On” and scroll down to the Volume option
4 Adjust the volume to 1, Press Save, and listen for the BEEP. A quieter audible beep should sound.
5 Select Audio Options again, go to the Volume option and adjust the volume to 5. Press Save, and listen for the beep. A louder audible beep should sound.
Audio is working if... Audio may not be working If...
You HEARD a beep
when you pressed save on your volume settings

AND

You HEARD the difference
between the two audio BEEP volumes (1 & 5).		 You DID NOT hear a beep
when you pressed save on your volume settings

OR

You HEARD a beep
when you pressed save on your volume settings,

but

You DID NOT hear a difference
between the two audio beep volumes (1 & 5)
Your pump is working as expected. Monitor your insulin pump closely and you can continue pump therapy. Visit https://www.medtronicdiabetes.com/checkaudio to start the replacement request process. If further assistance is needed, contact our 24-Hour Helpline 1-888-204-7616

NOTE: We recommend you repeat the Audio Beep test frequently as you continue to use your pump, or whenever you notice you may have not heard an alert or alarm that was displayed on the screen or resulted in a vibration.

Frequently asked questions


Yes, by definition, this is a recall for correction, as Medtronic is notifying customers of the issue and providing instructions to address the issue.

FDA uses the term “recall” when a manufacturer takes a correction or removal action to address a problem 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. A medical device recall does not always mean that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. (https://www.fda.gov/medical-devices/medical-device-recalls/what-medical-device-recall).

Because the safety of our customers is our top priority. Medtronic is starting a Field Corrective Action to inform customers about rare occurrences in which the MiniMed™ 630G and MiniMed™ 670G insulin pumps with version 4.10 software have not made expected audio sounds during alerts, alarms, or sirens associated with how the pump is working, and with high or low glucose alerts.
    No. This potential issue may only impact the insulin pump systems with 4.10 software version: MiniMed™ 630G and MiniMed™ 670G insulin pump globally. Pumps that do not have software version 4.10, along with Motor App version 2.6A, listed in the Notified Pumps table are not affected by this issue.
No. This issue does not impact any of the Paradigm platform pumps or the MiniMed™ 530G system.
Medtronic is sending a notification to customers who received a potentially affected pump, as well as sending notifications to their healthcare professionals. Medtronic is also updating the pump software to resolve this issue.
The software that resolves this issue is already included in pumps shipping in the U.S.
This is a global field corrective action—all countries worldwide where these insulin pump models are available are affected. Note: Please refer to the Notified Pumps section of this document.
No, they are not related.
No, this is a separate issue.