Users of the t:slim X2 insulin pump are being made aware of a malfunction that could stop the device from working.

The Therapeutic Goods Administration (TGA) has that certain versions of the insulin pump have a wiring problem with the speaker that could stop the delivery of insulin.

Australasian Medical and Scientific Ltd (AMSL) alerted the TGA to the failure which appears on device screens as Malfunction Code 16-0x20E6, or simply ‘Malfunction 16’. 

ARTG number	Catalogue number	Multiple serial numbers
304681	1002717	5317 unique serial numbers identified in Australia

What are the risks?

The problem could:

• Stop insulin delivery and disconnect the pump from the Continuous Glucose Monitoring (CGM) and mobile app.
• Lead to hyperglycaemia if not addressed promptly.
• Require patients to seek medical intervention or hospitalisation in serious cases.
• Result in loss of real-time glucose data and trends.

What should I do?

• If Malfunction 16 has not occurred:
  • Continue using your pump as per the user guide.
  • Install the Tandem t:slim mobile app and enable push notifications. This ensures that if the problem does occur, you will be notified by the app.
  • If using a Dexcom sensor, use the Dexcom mobile app as a backup source for CGM alerts and alarms.
• If a Malfunction 16 occurs:
  • Acknowledge the alert by pressing “Silence Alarm.”
  • Contact AMSL Technical Support at 1300 851 056, who will arrange for a replacement pump.
  • In the meantime, switch to your backup insulin delivery method.

You should continue to monitor your blood glucose levels regularly and ensure a backup insulin method is available as per the pump training and user guide.

Further information

Please contact AMSL on 1300 851 056 for further information. 

A software update is in development that will improve early detection of speaker failure and introduce persistent vibration alerts. Pump users will be notified when this software update becomes available.

Reporting problems

Consumers and health professionals are encouraged to . Your report will contribute to our monitoring of these products. For more information see the .

The TGA cannot give advice about an individual’s medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.

With no family history of type 1 diabetes, Melanie didn’t anticipate her son Andrew’s diagnosis at 7 years of age. “We didn’t have the right level of coverage for an insulin pump. We had to upgrade and pay a much higher insurance premium. As diabetes was considered a pre-existing condition on our new coverage, we had to serve a 12-month waiting period.”   

Currently, less than 50% of Australians have private health insurance, and only a third of them hold the gold tier policies that provide the necessary coverage for privately insured patients to receive access to insulin pumps. This means that even for the majority of Australians who have private insurance coverage, there is no option but to self-fund the purchase of insulin pumps¹.  

For Melanie, waiting 12 months for this life-saving device was not an option.  

“Andrew had met a local ‘ the same age, and this boy had a pump. Andrew watched him being able to eat whenever and just press some buttons on his pump.

“He told me that night he wanted to ask Santa for an insulin pump for Christmas.”

“I told him I would figure it out and get one as soon as I could, but that he wasn’t to waste his Christmas wishes on diabetes stuff. I applied for a loan pump to cut down our wait time, and hired a private diabetes nurse educator to avoid the long wait in the public clinic. We didn’t quite make the Christmas deadline, but we got him up and running in the January.”   

Three years on and Melanie’s entire family have top tier insurance coverage that costs hundreds of dollars a month. They made this decision because they also have a daughter, and she now has a higher risk of being diagnosed with type 1 diabetes. Melanie doesn’t want to risk her being diagnosed with type 1 diabetes and then having to wait 12 months to access an insulin pump.  

Looking ahead, Melanie has significant concerns about the affordability of diabetes technology for Andrew who will have the added financial burden for the rest of his life. She wants him to experience the freedom that someone with a working pancreas has – to be able to travel as a young person, move away from home, work on a mine site, or live overseas: “Whatever he wants to do without worrying about that financial cost of what he needs to be healthy and safe.” 

Watch Melanie & Andrew’s story: 

¹ Medical Technology Association of Australia 

Holly was diagnosed with type 1 diabetes at six years of age, but it wasn’t until she was 28 that she had her first ever full night of sleep. This was thanks to her Automated Insulin Delivery (AID) system.  

AID systems combine insulin pumps and continuous glucose monitors, automating insulin delivery and improving quality of life. Before having an AID system, Holly had a manual pump and a CGM.  

“You have all the information with the CGM
 you can see what’s happening minute to minute. But then I had to make all the treatment decisions,” says Holly.  

She found the heavy burden of constant decision-making overwhelming. It led to extreme levels of diabetes distress.   

Fortunately today, life looks a lot different for Holly.  

“My life is so much easier on an automated instant delivery system
 when you transition to a system like this and you’re no longer making these decisions, you have capacity to think about the other things in your life that aren’t diabetes. And so it’s honestly life changing.” 

Holly feels extremely fortunate to be able to access her AID system through her private health insurance, and strongly believes the current disparity in affordable access to diabetes technology needs to be addressed. 

Watch Holly’s story:

Concerned about starting insulin? You’re not alone. Many people moving on to insulin have questions and you are not expected to know all the answers. We answer some of the most common below, but if you have more it’s a great idea to make a list of questions to take to your doctor. Your doctor will appreciate anything you mention, as it will help them to offer you the best possible support. For more information please read this or call the NDSS Helpline 1800 637 700 to talk to a health professional.

Will I get hypoglycaemia?

Your doctor will start you on a low dose of insulin and increase it slowly. This should reduce the risk of . Make sure you are eating regularly. If you change your diet or physical activity levels, consult your doctor about your insulin dose. This explains how to reduce your risk of having a hypo and how to manage them.

I hate the thought of needles, will injections hurt?

Most people now use pre-filled pens to inject insulin. These are simple to use and often a lot less painful than measuring your blood glucose levels (BGLs).

The first time you inject you will probably be quite nervous, but as with all things we continue to do it gets much easier with practise. Your practice nurse or diabetes educator will go through what to do and will be happy to help you refine your technique.

I am concerned this will disrupt my life

The devices for injecting insulin are easy to use and reliable. You may have to check your blood glucose levels more often; however, starting insulin can give you a lot more energy and a lot fewer symptoms. There are options for and for remembering to use your insulin. Insulin pens are portable for when you go out and can be administered discreetly as needed. Insulin will improve your long-term health giving you a better quality of life for longer.

I am angry. I did everything right why do I have to start insulin?

Diabetes is unpredictable and can make you feel out of control.  You may have done everything right from a medical perspective but things haven’t happened the way you planned. Anger is a natural reaction. Don’t let get in the way of keeping happy and healthy. If you can’t work through these feelings please talk with your doctor who may recommend you speak with a psychologist. It is a strength to ask for help when you need it. Staying angry will have a negative impact on your diabetes and your overall health and happiness.

I feel like I’ve failed. If I eat less and exercise do I have to start insulin?

Starting insulin is not a failure. You could eat practically nothing and exercise to exhaustion but still come to a point of requiring insulin. If you are taking medications now to lower your blood glucose you may be aware that they do not replace insulin. Oral and injectable (not insulin) medications work by helping the insulin your body produces work more efficiently. Once your pancreas is not making enough of its insulin you need to start supplementing insulin through injections. You may continue to take some of those medications as they will still help the insulin, both made by you and injected, work well. Insulin is just another medication to help you live well with diabetes.

Will I put on weight with insulin?

Starting insulin is a good time to check how much and how often you are eating carbohydrates during the day. A can assist you with getting this balance correct. If you overeat carbohydrates you will put on weight with insulin. This happens without injecting insulin as well. Insulin converts carbohydrates not used for energy into fat. If you are having to manage hypoglycaemia with carbohydrates talk with your doctor about getting your insulin doses correct. Starting insulin doesn’t have to lead to weight gain.

Does starting insulin mean my diabetes is becoming serious?

Diabetes should always be taken seriously. Often people start insulin when they are older. As your pancreas ages it needs a little help. Ageing brings lots of health concerns, so it is only natural to associate starting insulin with those health concerns. Starting insulin can keep you out of hospital and healthier and happier for longer. Delaying starting insulin can have serious consequences. Diabetes is no more serious when starting insulin. Insulin is just another tool to help you live well.

Donna Itzstein, Pharmacist and Credentialled Diabetes Educator

This article has been updated from the original article published in 2020.

On 18 September, Minister for Health and Aged Care, Hon Mark Butler MP, announced that Fiasp insulin will continue to be available on the Pharmaceutical Benefits Scheme (PBS) from 1 October 2023 for people living with diabetes.

This follows the announced removal by the supplier of the products Fiasp and Fiasp FlexTouch (forms of fast acting insulin aspart) from the PBS earlier this year.

How much will Fiasp PenFill cost?

The general patient PBS co-payment is $30 or $7.30 for concession card holders.

Does Fiasp PenFill contain the same insulin as the previously PBS-listed Fiasp FlexTouch?

Yes. It contains the same insulin (fast-acting insulin aspart) in the same volume as FlexTouch, but delivered through a different, newer device.

Which pen is compatible with the Fiasp PenFill^Âź insulin cartridge?

The Fiasp PenFill is approved for use with the NovoPen 6 as an insulin delivery device. The pen is available free of charge.  

NovoPen 6 is a new, smart insulin pen that automatically records insulin dosing information at each administration. This is a durable pen that Novo Nordisk says lasts for up to five years. It also automatically records the last dose and approximate time since the last injection.

People with diabetes can access a free NovoPen 6 through the NovoPen 6 Pharmacy Program. For more information go to the .

Fiasp PenFill can also be used with any reusable Novo Nordisk insulin delivery device, such as NovoPen4 and NovoPen Echo.

Please speak to your healthcare professional if you wish to use other devices or have any other questions. 

How do you use Fiasp PenFill cartridges?

Fiasp PenFill is administered 5 to 10 minutes before eating a meal. It is administered subcutaneously in the abdomen, buttock or thigh. Please speak with your healthcare professional/diabetes educator for information specific to your needs.

How many units are in a Fiasp cartridge?

Each cartridge contains 300 units of insulin aspart in 3mL solution.

Does Fiasp come in half unit pens?

Yes. The 3mL Penfill cartridges are for use with some Novo Nordisk insulin delivery devices and 4-6mm pen needles. When the cartridge is used with the NovoPen Echo, the pen offers half-unit dosing and a memory function.

Can I take Fiasp after I eat?

Yes. Fiasp can be taken at the start of a meal or within 20 minutes after starting a meal.

How long does Fiasp take to lower blood glucose levels? Depending on the amount taken, Fiasp begins lowering glucose in 15 to 20 minutes, and has a peak glucose-lowering effect in about 1.5 to 2 hours.

șÚÁÏÍű has welcomed the announcement by Minister for Health and Aged Care, Hon Mark Butler MP, that Fiasp insulin will continue to be available on the Pharmaceutical Benefits Scheme (PBS) from 1 October 2023.

Minister Butler has announced the new listing of Fiasp Penfill which contains the same insulin (fast acting insulin aspart) in the same volume as the previously PBS listed Fiasp FlexTouch, but is delivered through a different device.

This follows the announced removal by the supplier of the products Fiasp and Fiasp FlexTouch (forms of fast acting insulin aspart) from the PBS earlier this year.

Over the last 6 months the Government has negotiated with drug sponsor Novo Nordisk to list Fiasp Penfill as a new form of the fast acting insulin aspart.

During this period, șÚÁÏÍű, along with our unifying health partner organisations the Australian Diabetes Society and the Australian Diabetes Educators Association, has been advocating to represent the voice of the community to both Government and Fiasp manufacturer, Novo Nordisk.

This announcement will bring significant relief for the 15,000 Australians living with diabetes who use Fiasp.

șÚÁÏÍű Group CEO Justine Cain applauded Minister Butler’s intervention which allows ongoing access to the insulin used by around 15,000 Australians living with diabetes.

“Minister Butler has demonstrated that the Albanese Government understands how important it is to give people living with diabetes access to the affordable medicines and technologies they need to manage the condition,” Ms Cain said.

“Diabetes is a demanding and complicated condition that needs constant monitoring.

“Australians living with diabetes need access to the best available insulins and medicines, at affordable prices, to have their best quality of life and reduce the impact of diabetes-related complications,” Ms Cain said.

Read .

șÚÁÏÍű have been consistently talking with both the Federal Government and Novo Nordisk about the need for a solution before 1 October 2023.

We have been advised that negotiations are continuing.

Both the Government and the manufacturer have been made aware of the significant angst this is causing the diabetes community 

șÚÁÏÍű will continue to advocate on this issue. We have set up a page – Fight for Fiasp – where you can lend your voice and advocate on this issue.

We will keep you updated, as and when we hear anything on this issue.

The Therapeutic Goods Administration (TGA) has advised of a current shortage of Ryzodeg 70/30 FlexTouch insulin prefilled pens. The shortage is expected to continue until mid-next year.

To help manage the shortage, pharmacists can give people living with diabetes Ryzodeg 70/30 Penfill cartridges instead of Ryzodeg 70/30 FlexTouch prefilled pens under certain conditions. Both products contain the same medicine, at the same strength, have the same storage requirements, and are administered by injection under the skin (subcutaneous injection). However, the device used to administer the medicine is different.

If you have been prescribed Ryzodeg 70/30 FlexTouch insulin prefilled pens, it’s important to speak with your pharmacist, doctor, diabetes educator or nurse who can explain to you the differences between FlexTouch prefilled pens and Penfill cartridges, how to administer them, and provide you a new delivery device (a NovoPen) for free.

The provides additional information about the shortage and guidance for users of Ryzodeg 70/30 FlexTouch insulin prefilled pens.

In recent weeks the US Food and Drugs Administration (FDA) has approved Beta Bionics for use by people over 6 years of age living with type 1 diabetes in the US.

When paired with the Dexcom G6 continuous glucose monitor, the pocket-sized device can deliver tailored insulin doses every five minutes, based on calculations of current and past glucose levels and the body’s reaction to previous insulin deliveries. Where a standard insulin pump must be adjusted manually based on what the user estimates the carbohydrate count of their meal to be, the bionic pancreas adjusts insulin levels internally through communication with the Dexcom G6. This allows blood glucose levels to be regulated with minimal input from the user. At set up, all that is needed is for the wearer to enter their weight and following that the only interaction needed is to input an estimation of whether a meal is low, medium, or high in carbohydrates.

In the iLET Bionic Pancreas was found to be effective in keeping blood glucose levels in target range for 11% longer than when participants were using their usual diabetes technology. The device was also found to reduce HbA1c levels across all the participant groups, regardless of their ethnic background, education, or income level. 

Beta Bionics says the device provides more flexibility in type 1 diabetes management and takes away the constant measuring of blood glucose levels and calculations for insulin doses that so many living with type 1 diabetes have to do each day. 

The approval by the FDA in the US is a huge milestone in a two-decade journey for Ed Damiano who was inspired to develop the system after his son was diagnosed with diabetes when he was just 11 months old.

“This milestone is particularly poignant to me as the news of FDA clearance coincided with the 24th birthday of my son, David, who developed type 1 diabetes as an infant, just over 23 years ago,” Damiano, founder and executive chairman at Beta Bionics, told Boston University’s The Brink.

The iLET Bionic Pancreas is currently only available in the US. 

Over the last few years tubeless insulin pumps have been approved for use in Australia.

These insulin pumps, sometimes called tubeless patch pumps or pod pumps, do not have tubing as part of the infusion set, instead only a small cannula to facilitate insulin delivery. They attach to the skin so there is no need to worry about clothing choices to accommodate carrying your pump.

The two pumps on the market in Australia are  and  Both pumps are very small and both weigh less than 30g.

How do these pumps work?

The pumps do not have a screen so they use a personal delivery manager (PDM) or receiver to send information to the pump for insulin delivery. The PDM is similar to a smart phone. Unfortunately, to date there is not an app to control these pumps so the user needs to have a smart phone for their continuous glucose monitor (CGM) and a transmitter (PDM) for the pump.

As the CGM and micro pumps do not communicate with each other, the option of auto-stop or auto-basal adjustment is not available.

One advantage of these pumps is that they can be worn on the back of the arms, stomach, thighs or buttocks, providing more flexibility in regards to placement sites of traditional tubing pumps.

Here’s a side-by-side comparison of the two:

	Accu-Chek Solo	Omnipod DASH
Cost	Covered by private health insurance and disposable parts subsidised by NDSS for eligible persons. Not yet available for new customers, just existing.	Free if covered by private health insurance, or a subscription fee to Insulet Australia of $168.27/month plus the cost.
Waterproof	No.  Needs to be removed from pump holder while in water.	Waterproof with an IP28 rating for up to 7.6 metres for 60 minutes.
Reservoir	200 units	200 units
Wear time	Pump base replace every 4 months​. Cannula and pump holder maximum wear is 3 days​. Reservoir maximum wear is 4 days.	Replace pod every 3 days.
Data Upload	Accu-Chek software.	Upload data to Diasend or Glooko.
Bolus	Bolus calculator. Able to do small bolus with bolus button or precise bolus with PDM.	Bolus calculator. Bolus using PDM.
Basal	5 different basal rates.	12 different basal rates.
Blood glucose checking	Transmitter uses Avivia test strips.	Manual input data from blood glucose meter or CGM/flash glucose monitor
Dimensions	Approximately 63 x 39 x 14 mm (LxWxH)	52mm x 39mm x 14.5mm (LxWxH)
Weight	Less than 29g with a filled reservoir	26g

If you are considering a pump

There are now five different insulin pump brands available in Australia. Each pump has different capabilities and suits different individuals.

When deciding on an insulin pump it is recommended you talk to your diabetes healthcare team and discuss what you would like from a pump and how a pump will fit into your lifestyle.

By Polly Antees APD CDE