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Urgent - Product defect correction

MiniMed™ remote controller (MMT-503)

TGA Reference: RC-2018-RN-01123-1
ARTG: 128416

If you are using an optional MiniMedTM remote controller model number MMT-503, this notification is to inform you of a potential security risk related to the Medtronic MiniMedTM ParadigmTM series insulin pumps when using the corresponding MiniMedTM remote controller.

Problem/Issue Description: 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.

The following list shows the Medtronic remote controller and compatible Medtronic insulin pump(s) that are vulnerable to this issue.

Several factors must occur for the pump to be vulnerable:

1. The remote option for the pump would need to be enabled. This is not a factory-delivered default, and a user must choose this option.

2. The user's remote controller ID needs to be registered to the pump.

3. The Easy Bolus™ option would need to be turned on and a bolus step size programmed in the pump.

4. An unauthorized individual would need to be in close proximity of the user, with necessary equipment to copy the RF signals activated, when the user is delivering a bolus using the remote controller.

5. The unauthorized individual would need to be in close proximity of the user to play back the RF signals to deliver a malicious remote bolus.

6. The user would need to ignore the pump alerts, which indicates that a remote bolus is being delivered.

Protecting the security of your insulin pump If you or your patients are concerned but want to continue to use the convenience of the remote controller, the following are some precautions you can take to minimize risk:

  • Turn off Easy Bolus™ feature when not intending to use the remote bolus option
  • Be attentive to the pump alerts, especially when the easy bolus option is turned on, and immediately cancel any unintended bolus
  • Do not connect to any third-party devices not authorized by Medtronic

Please note that if you have never programmed a remote controller ID into your pump and never programmed the Easy Bolus™ option, you will not be impacted by this vulnerability.

The MiniMed™ Paradigm™ family of insulin pumps remain safe and effective for diabetes management, so Medtronic encourages you to continue your therapy as you normally would and take these precautionary steps if you are concerned.

Additional Information

Medtronic is initiating this action in consultation with the Therapeutic Goods Administration.

Local contact details

If you have further questions or need assistance, please call the Medtronic Diabetes Helpline on 1800 777 808.