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SAFETY ALERTS 

PUTTING SAFETY FIRST

SAFETY ALERTS PUTTING SAFETY FIRST

UNDERSTANDING OUR PRODUCTS

If for any reason a Safety Alert or Product Recall is issued, we want you to know about it. As part of our commitment to patient safety, the latest in this information is updated on this page.

 

16th July 2020 – Guardian Connect App Connectivity to CareLink Personal Software

We released an update to the CareLink Personal software on Saturday, June 28, 2020. Following this release, some customers using the Guardian™ Connect app on iOS devices experienced data connectivity disruptions to the CareLink™ software. As a result, the following disruptions may occur:

  1. Care partners may not receive SMS alerts from the Guardian Connect app
  2. Care partner remote access monitoring in the CareLink Connect web app may show data gaps
  3. You may see data gaps in CareLink reports

Please note, normal use of your Guardian™ Connect app is not impacted – you will still be able to view your CGM data and receive alerts in your Guardian Connect app.

Actions Required: Check If You Are Experiencing the Issue
(refer to the Frequently Asked Questions included for detailed instructions)

1. Attempt to manually upload your data to the CareLink™ software via the
Guardian Connect app:

  1. Tap  on the top left corner of the Home Screen
  2. Confirm “Sync to CareLink” is enabled
  3. Tap “Upload Now”
  4. Wait 10 minutes before moving to step #2

 

2. Check your account to see if you are experiencing this issue

  1. From your mobile device visit  https://carelink.minimed.eu and log
    in to your CareLink™ account
  2. Confirm that your data is visible in the CareLink™ Connect web app
  3. If your data is visible, no further action is needed - you are not
    experiencing the issue
  4. If your data is not visible, you may be experiencing the issue and
    you should complete the steps in the next section to resolve the
    issue.

Instructions for Resolving the Issue
(refer to the Frequently Asked Questions included for detailed instructions)

1. If your data was not visible after step #2, uninstall the Guardian™ Connect app from your mobile device. For help, please refer to FAQ below #3

2. Unpair your transmitter from your mobile device. For help, please refer to FAQ below #3

3. Re-install the Guardian™ Connect app on your mobile device – this will restore the CareLink™ connection. For help, please refer to FAQ below #4

*Uninstalling the Guardian™ Connect app may delete visible data from the app. All data that has been uploaded to the CareLink™ software will continue to be visible in CareLink™ reports. However, any data generated since June 28, 2020 may not have been uploaded.

 

13 Feb 2020 – MiniMed 600 Series Insulin Pump (MMT-1782, MMT-1711)

IMPORTANT UPDATE: AUSTRALIAN MINIMED PUMP USERS

You may have seen a post by the U.S. Food and Drug Administration (FDA) on 12 February to classify a potential issue with the MiniMed™ 600 series insulin pumps. The classification related to a loose, damaged or missing retainer ring and was recorded as a Class I recall by the U.S. FDA. This recent classification of the recall does not introduce any new issues or generate new instructions for customers to return product that is working properly. This information is for the U.S. only.

In November 2019, we proactively notified customers in Australia about this potential issue through a Medical Device Safety Alert. Our advice for Australian customers remains the same:

  • Examine the retainer ring on your pump.
  • If the reservoir does not lock into the pump or the retainer ring is loose, damaged or missing, discontinue using the insulin pump and revert to a back-up plan of manual insulin injections per your doctor’s recommendations. DO NOT insert the reservoir back into your pump while connected because you could mistakenly give yourself a large insulin bolus, and contact our Medtronic 24-Hour Technical Support line at 1800 777 808.
  • If your reservoir properly locks in place by the retainer ring, continue to use your pump. Remember to always follow the Instructions for Use on how to correctly insert the reservoir.

Please contact your healthcare professional or the Medtronic 24-Hour Technical Support line at 1800 777 808 with any questions.

 

Clearing alerts on the MiniMed® 640G System^  22nd July 2015

If your patients are using the MiniMed® 640G System^, they may receive an alert when performing a bolus, related to either having dangerously low blood glucose, dangerously high blood glucose or are trying to deliver a large Bolus (as shown in the pictures). It is important that they clear these alerts immediately so that they can correctly deliver the bolus. It is also important to never use data older than 12 minutes to determine a Bolus amount.

Low BG         High BG         Max Bolus

For more info, download the letter sent to MiniMed® 640G users.

Read the letter

Medtronic MiniMed® Sure-T infusion sets Recall for Product Correction  23rd June 2015

Potential for interruption of insulin delivery and/or infection due to needle breaking during use
Medtronic, after consultation with the TGA (TGA Ref# RC-2015-RN-00506-1), is initiating a voluntary Recall for Product Correction for the above mentioned devices. As part of Medtronic’s product quality monitoring process, we identified that certain MiniMed® Sure-T infusion sets* had a slight increase of reported cases where the steel needle broke during use. In a small number of these reported cases, the needle break led to hospitalization for the management of glucose levels and/or treatment for removal of the needle. Since then, an improvement in the needle manufacturing was implemented, which has reduced the number of reported cases of needle breaks. 

For more info, download the letter sent to MiniMed® 640G users.

Read the letter

MiniMed® remote controller (MMT-503) TGA Reference: RC-2018-RN-01123-1 ARTG: 128416 - 16 Aug 2018

The Medtronic remote controller, which uses a wireless (RF) radio frequency to communicate with your insulin pump, helps in programming a set amount of insulin (or bolus) into your Medtronic pump discreetly while keeping your device concealed.

An external security researcher has identified a potential vulnerability related to the MiniMed® Paradigm™ family of insulin pumps and corresponding remote controller. The researcher’s report states that an unauthorized individual in close proximity of an insulin pump user could potentially copy the wireless radio frequency (RF) signals from the user’s remote controller (while they are in the process of delivering a remote bolus) and play those back later to deliver an involuntary Bolus of insulin to the pump user. This could lead to potential health risks such as hypoglycemia if additional insulin is delivered beyond the user’s insulin requirements.

Read the letter