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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.

 
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Urgent - Medical device product defect correction

MiniMedTM 640G Insulin Pump (MMT-1711)

TGA Reference: RC-2018-RN-01321-1
ARTG: 95763

Medtronic have received reports of occurrences in which the MiniMed™ 640G 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 patient's personal setting, or it could make no sound. Either of these occurrences could cause your patient to miss system notifications, alarms or sirens associated with how the pump is working, and with high and low glucose alerts. The purpose of this letter is to make you aware that we will be notifying all patients who may have one of the potentially affected insulin pumps. Patients will be emailed and/or sent a letter with information specific to the insulin pump model they are using.

The letter being sent to MiniMedTM 640G users will explain that they should enable the Vibrate feature and perform an Audio Beep test:

The Vibrate feature should be enabled on the pump and your patient should verify that it remains enabled with every set change. Even if the Audio Beep test passes, the Vibrate feature should be enabled (in addition to the Audio feature) since it will add an additional notification to any alerts or alarms received on the pump.

Follow the steps below to enable both the Vibrate and Audio feature on the insulin pump.

An Audio Beep test should be performed to see if the pump is experiencing this potential issue. This test will identify if the pump audio is working. The steps for this test can be found in the patient letter, and users can also access the website that will guide them through this process at https://pump.medtronic-diabetes.com.au/req-call-alert/

Important note: This test should be repeated with every set change and once mid-way through the infusion set use to verify the continued audio functionality of the pump.

If the pump fails the beep test, it will not permanently regain its audio capabilities and a replacement will be required to use the audio features of the pump. Even if the pump passes the Audio Beep test, patients should continue to perform regular beep tests to ensure continued audio functionality.

If you have concerns about monitoring your pump for this issue, we recommend to register at https://pump.medtronic-diabetes.com.au/req-call-alert/ and Medtronic Helpline will contact you within 5 business days to discuss potential options.

Problem/Issue Description: This issue occurs when a specific electronic component in the 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 the patient's ability to respond 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 the pump, the audio cannot be permanently repaired or regained. The only way to permanently regain audio capabilities is to exchange the affected pump with a replacement. Even if the 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 the pump contains the specific electronic component, and the pump passes the Audio Beep test described below, there is still a chance that the pump may lose its audio capabilities at some future date. The occurrence rate for this malfunction is between 0.14% and 0.3%. To address this issue, Medtronic Australia have updated the Diabetes Support Guides and Manuals webpage to include the Audio Beep Test Instructions which can be found here: https://www.medtronic-diabetes.com.au/support/guides-and-manuals

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 our support line at 1800 777 808

AUDIO BEEP TEST

Follow the steps listed below to determine if your pump is experiencing this issue. You may also use the following website to help you go through this process: https://pump.medtronic-diabetes.com.au/req-call-alert/

 
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2018 Live It Up Lottery

Live-it-up-2018Your support is greatly appreciated as it enables us to raise awareness, provide education and support research – for people living with, or at risk of developing diabetes.

For just $30 for 6 tickets or $5 a ticket you will help make a difference and go into the draw to win $20,000 cash.

To find out how to purchase tickets call 8234 1977, email This e-mail address is being protected from spambots. You need JavaScript enabled to view it or visit our office at 159 Sir Donald Bradman Drive, Hilton.

2018 Live It Up Lottery prizes

  • First prize $20,000 
  • Second prize $5,000 cash
  • Third prize $3,000 cash
  • Early Bird prize Win $1,000 – purchase 6 tickets or more by 16 November 2018 to enter the draw
  • VIP prize Win $1,000 – purchase 6 tickets or more to enter the VIP draw (become a VIP to be included in the next lottery)

Important dates

  • Friday 16 November 2018 – purchase 6 tickets or more to be included in the Early Bird prize,
  • Wednesday 12 December 2018 – lottery closes,
  • Friday 14 December 2018 – lottery drawn at 118 Richmond Road, Marleston

It's easy to purchase tickets, you can simply:

  • Call us today on 08 8234 1977 and make a payment over the phone
  • Come to our office at 159 Sir Donald Bradman Drive, Hilton to complete your purchase.

Join our VIP list

Increase your chances of winning by entering our VIP list

Already a VIP?

The launch of our new lottery has seen some changes made for our VIP lottery members.

If you wish to purchase tickets, we are now sending our VIPs an order form. Once you return this and we receive payment, you receive a confirmation letter with your ticket numbers, which we can post or email you. This change helps us reduce costs and enables us to spend our much-needed fundraising dollars on our programs.

We have listened to your feedback and increased the ticket price to $5. We plan to sell the tickets in lots of six – making the total cost only $30. We would be delighted if you could support Diabetes SA by purchasing lottery tickets. Even better, if you are happy to receive your tickets by email in our next lottery, please tick the box and add your email to the order form.

Licence No M13553. Number of tickets 30,000. Conducted by Diabetes SA. Proceeds in aid of information, support and education. Drawn 1.00pm 14 December 2018 at 118 Richmond Road Marleston SA. Results published in the Advertiser on 19 December 2018.

 
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Do you have a child at school who is living with type 1 diabetes? 

You are invited to take part in a national conversation about the future of type 1 diabetes management in schools across Australia.  

The Australian Government has asked Diabetes Australia to develop a new nationally consistent training and education program to support type 1 diabetes management in schools. 

Diabetes SA already delivers diabetes education and support to schools across South Australia. This project will build on these services and help establish an approach that can be tailored to suit the individual circumstances of all schools in Australia.  

Your experiences will help us understand how SA schools are supporting children with type 1 diabetes.

Let us know: 

  • What works well? 
  • What needs to be improved? 
  • What support and information do you use that is helpful? 
  • Are the needs different in primary school and secondary school? 
  • Who should be responsible for what? 

Your insight will help us develop a national training and education program to support schools to manage students with type 1 diabetes. 

PricewaterhouseCoopers (PwC) have been engaged to help us with this project and they have arranged several consultation sessions. Please register for one of these sessions from the dates listed below. Workshops will be held at Quest on Franklin - 74 Franklin St, Adelaide.

If you live in regional South Australia or you can’t make it in person but still want to join in the conversation – we can link you in by video or phone conference (please email  This e-mail address is being protected from spambots. You need JavaScript enabled to view it  and indicate you would like join a session via phone).

For Parents and Carers

Places are limited, so please register ASAP. 

If you need parking close to the workshop location please email This e-mail address is being protected from spambots. You need JavaScript enabled to view it  and they will be able to assist. 

We know the consultation period is limited, but we really appreciate any effort you can make to participate. Your views and experience will help us get this right.  

If you can’t attend, then we still want to hear from you!  

You can access an online survey from the 3 – 31 October 2018 here.

…and if you know of anyone who you think would be interested in attending, please pass on this invitation.

We will be also be consulting with principals, teachers and school staff.

If you know of any school staff, who would like to participate in consultation please ask them to email This e-mail address is being protected from spambots. You need JavaScript enabled to view it .  

Any questions? Please contact This e-mail address is being protected from spambots. You need JavaScript enabled to view it .  

 

ndss-15mm

The National Diabetes Services Scheme (NDSS) is an initiative of the Australian Government administered with the assistance of Diabetes Australia.

 
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World Diabetes Day Seminar – Research & Innovation

World Diabetes Day on November 14 is a worldwide diabetes awareness campaign. Every year World Diabetes Day reaches more than 1 billion people in over 160 countries and aims to highlight key issues relating to diabetes.

World Diabetes Day this year will be honoured with two concurrent seminars from Diabetes SA. The first seminar will focus on the latest research and innovations for people living with type 1 diabetes and their families, and the second seminar will present two expert speakers focused on informed research for people living with type 2 diabetes and their families.

Concurrent Seminar 1 – Type 1 Diabetes

WDD16-seminarGuest speaker Professor Toby Coates will discuss the latest research and innovation: “Treating diabetes in new ways in SA: islets transplanted in the skin and the new whole pancreas transplants – two unique programs only offered in SA.”

Guest speaker Dr Jessica Stranks will discuss up-to-date diabetes technology: “Technology and Diabetes – to infinity and beyond!”

Event details

  • Date: Wednesday 14 November 2018
  • Time: 6.30pm – 9.00pm. Light refreshments will be provided at 7.30pm
  • Venue: Riverbank Rooms 6, 7 & 8, Adelaide Convention Centre, North Terrace, Adelaide
  • Cost: This seminar is FREE to people registered with the NDSS
  • Click here to book online.

Concurrent Seminar 2 – Type 2 Diabetes

shopping-familyGuest speaker Professor Christopher Rayner will discuss his research into gut function: “A bittersweet story: harnessing nutrients to modify gut function and control diabetes”.

Guest speaker Miriam Henke, Health Psychologist with a special interest in Mind-Body Medicine will discuss: “Mental wellbeing for the whole family: How to best care for yourself and your loved ones when diabetes is a part of your everyday life.

Event details

  • Date: Wednesday 14 November 2018
  • Time: 6.30pm – 9.00pm. Light refreshments will be provided at 7.30pm
  • Venue: Riverbank Rooms 6, 7 & 8, Adelaide Convention Centre, North Terrace, Adelaide
  • Cost: This seminar is FREE to people registered with the NDSS
  • Click here to book online.

In addition, there will be trade displays for people living with type 1 and type 2 diabetes including the different insulin pumps, smart meters and continuous blood glucose monitoring devices.

ndss-15mm

The National Diabetes Services Scheme (NDSS) is an initiative of the Australian Government administered with the assistance of Diabetes Australia.

 
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Australasian Diabetes Congress 2018

The Australasian Diabetes Congress was held this year from 22–24 August 2018 at the Adelaide Convention Centre. The Australasian Diabetes Congress is a premier event for all health professionals specializing in diabetes, working with people with diabetes or having an interest in diabetes.

This was also a very exciting event for Diabetes SA, as we had an information stand in the exhibition hall, with the potential of reaching lots of health professionals working in the field. Five of our abstracts were accepted, resulting in three poster presentations and two oral presentations.

Click here to see photos from the Congress.

ADEA oral presentations

Diabetes SA had two oral presentations on Thursday 23 August, providing an update about recent work undertaken by the health services team in the culturally and linguistically diverse area, and sick day management in correctional facilities. 

Claire Oliver, Diabetes SA: The learning styles of diabetes education for culturally diverse health care workers and professionals in various cultural primary care settings: the learning from experiences.

ADEA18-Claire-poster

Fiona Benton, Diabetes SA: A recommendation for sick day management of adults with diabetes in a correctional facility

ADEA18-Fiona-poster

Highlights from the Australasian Diabetes Congress 

ADS Clinical Symposium – Development and Implementation of the South Australian Aboriginal Diabetes Strategy (by Trish Evans, Diabetes Educator)

I had the privilege of listening to Kim Morey from Wardliparingga Aboriginal Research Unit at SAHMRI on North Terrace discuss the Development and implementation of the South Australian Aboriginal Diabetes Strategy 2017-2021.

The vision of this strategy is to lessen the burden of type 2 diabetes in Aboriginal people, their families and communities. Kim discussed the disparity of 10 years in life expectancy in Aboriginal people and chronic disease is the leading cause of this.

Highlighting Aboriginal people live with diabetes '2 times the rate of the general population'.

Kim outlined the six high level goals to reduce the impact of type 2 diabetes in the Aboriginal population in the next 5 years:

  1. Reduce the incidence of type 2 diabetes and gestational diabetes.
  2. Detect type 2 diabetes early
  3. Improve diabetes care and reduce its complications
  4. Reduce the impact and incidence of diabetes in pregnancy
  5. Reduce the incidence of and better manage type 2 diabetes among priority groups
  6. Strengthen research, data usage and population health monitoring

This Strategy has been developed by Aboriginal people and has been planned to meet the needs of Aboriginal people who live in South Australia. Click here for more information.

Australian Diabetes Congress 2018 – ADS and ADEA Scientific meeting – Consumers Co-design (by Cathy Whiteley APD)

The ADEA Symposium session on consumers co-design was a fantastic session to highlight the importance of the principles of designing diabetes services and resources with people living with diabetes. The term co-design was coined for consumer involvement in developing services from beginning to end.

It focussed on 'Nothing about us without us' active involvement of consumers setting priorities in design, implementation and evaluation. Presenters were a combination of health professionals and peer supporters working together with the aim to make diabetes less stressful.

The resounding message was that people living with diabetes need to be seen as the experts, sharing their own narrative and the reality of life with diabetes. Together with co-design, this session also had a strong focus on the language used in diabetes stressing that to change the perception of diabetes, language matters.

Australian Diabetes Congress 2018 – ADS/ADEA Joint Clinical Symposium – Exercise as medicine – Nutritional management of exercise in type 1 diabetes (by Anissia Fairlie APD)

I had the opportunity to attend Dr Carmel Smart's presentation on exercise and type 1 diabetes. She discussed the importance of adequate nutrition, hydration and insulin adjustment before, during and after exercise to optimise performance, recovery and safety.

Australian Diabetes Congress 2018 – The Dark Side of Diabetes (by Kimberley Zerk, Diabetes Educator)

The Dark Side of Diabetes, conducted by Prof Jonathan Shaw, head of Clinical Diabetes at Baker Heart and Diabetes Institute explored diabetes-related-cardiovascular complications. CVD is the most important complication of type 2 diabetes. The risk for the development of CVD is even more pronounced in women, those with early-onset diabetes (before 40 years of age), and Indigenous Australians. However, interventions that can significantly reduce cardiovascular risk. Click here to view this report.

Australian Diabetes Congress 2018 – Clinical Management of Diabetes Neuropathy (by Kimberley Zerk, Diabetes Educator)

Eva Feldman, Professor of Neurology at the University of Michigan discussed the Clinical management of diabetic neuropathy in Pre-diabetes and diabetes. She stated that it has long been suspected that glycaemic management, while being a crucial factor in diabetic peripheral neuropathy, is not the only one. Her research has shown that Metabolic syndrome, prompted by obesity and a driver of dyslipidemia, also has a considerable impact. In fact, her study showed that obesity alone can cause neuropathy.

Australian Diabetes Congress 2018 – ADEA Kidney Health in Diabetes – Connecting Chronic Kidney Disease: the link with Diabetes (by Claire Oliver, APD)

Shilpa Jesudason provided a vibrant and practical session highlighting the importance of kidneys and their link with diabetes and cardiovascular disease. The main take-home message for me from this presentation was to think more about the kidneys, as diabetes is the leading cause of Chronic Kidney Disease (CKD).

Australian Diabetes Congress 2018 – ADEA Diabetes Research Foundation Showcase – Optimising mealtime insulin bolusing algorithms (by Claire Oliver, APD)

Kristine Bell provided an overview of her current research into the effect of fat intake on glycaemic response. Kristine presented some emerging data on how the amount of fat in a meal may significantly affect blood glucose response and considerations for insulin adjustments depending on the nutritional composition of a meal.

Australian Diabetes Congress 2018 – ADEA Diabetes Research Foundation Showcase – Not scared of sugar (by Claire Oliver, APD)

Tammie Choi presented interesting information on the delivery of a diabetes program to a Chinese community. Tammie included humorous anecdotes from her own experience as an Australian-trained Dietitian from a Chinese background. The focus was on the delivery style of this program and some key messages for clinicians to consider when providing information to someone from a Chinese background. This is a considerably different approach to how many other cultures prefer to receive information and their involvement in their healthcare.

 
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