FAQs and information - MallyaD2 USA

USA

Indication for use

The Mallya^®D2 Injection Pen Adapter is indicated for the capture and wireless transmission of dosing information of compatible reusable and disposable pen injectors.

Device features

Mallya^D2 is able to :

• be assembled with Novo Nordisk® pen injector designed for diabetes treatment,

• record the amount of dose increments injected by the pen,

• record the timestamp (date & time) of each injection,

• transmit information relating to dose, time, and date of each injection to a mobile app on a smartphone, when the device is connected to it, using Bluetooth® technology.

Mallya^D compatibilities

Molecule	Concentration	Drug name in France
Degludec	100 IU/mL	Tresiba® 100 FlexTouch®
Degludec	200 IU/mL	Tresiba® 200 FlexTouch®
Detemir	100 IU/mL	Levemir® FlexTouch®
Aspart	100 IU/mL	Novorapid® FlexTouch®
Aspart	100 IU/mL	Fiasp® FlexTouch®
Degludec + Aspart	100 IU/mL	Ryzodeg® FlexTouch®
Degludec + Liraglutide	100 IU/mL + 3,6 mg/mL	Xultophy®
Semaglutide	1,34 mg/ml	Ozempic® 0,25 mg
	1,34 mg/ml	Ozempic® 0,5 mg
	1,34 mg/ml	Ozempic® 1 mg
Icodec	700 IU/mL	Awiqli® FlexTouch®

Distributor

If you have any questions/complaints, please contact:

1-609-987-5800
adressemail@help.us

NOVO NORDISK USA
800 Scudders Mill Road
Plainsboro, NJ 08536

Mobile application

Coming soon

Instruction
for use

Technical
note

FAQ

GENERAL QUESTIONS

What is Mallya^D2® ?

Mallya^D2® is a connected device compatible with the Novo Nordisk FlexTouch^® pens.

Mallya^D2® records information about the dose, time and date of each injection and transmits it via Bluetooth to a compatible mobile application.

How does Mallya^D2® work?

Mallya^D2® records dose data and shares this data with partner applications.

Mallya^D2® enables complete and accurate data tracking for patients and sharing with their healthcare team, when this functionality is activated in partner applications.

Why use Mallya^D2®?

Mallya^D2® enables you to manage your treatment by automatically collecting data and transferring this data to a mobile application.

Can I use more than one Mallya^D2®?

Absolutely. It is recommended that you use 2 Mallya^D2® devices, one for your fast-acting (bolus) insulin and one for your long-acting (basal) insulin if you are on a basal-bolus regimen. This is safest and the most convenient way to have all your insulin data in your logbook.

Can I use Mallya^D2® with any disposable pen?

Mallya^D2® is compatible with FlexTouch^®pens, and only with those. For a complete list of compatible pens, please refer to Mallya^D2® instructions for use (or find detailed information on www.my-mallya.com).

Can I use the same Mallya^D2® device with two or more connected devices?

It is not possible today to use the same Mallya^D® device on two or more connecte2d devices. In other words, a Mallya^D2® can be used with only one smartphone. If you wish to use Mallya^D2® with another phone, you will need to reset it.

Do I need medical clearance to use Mallya^D2®?

No, no medical authorization is required to use the Mallya^D2®. However, it is recommended that you discuss with your doctor prior to using Mallya^D2®.

How do I give my injections with ^D2®?

Once installed on your FlexTouch^® pen, Mallya^D2® does not interfere in any way with your usual way of performing an injection. Mallya^D2® can even guide you by indicating the end of your injection with a light signal. For more information, please refer to your FlexTouch^® pen and Mallya^D2® instructions for use.

TECHNICAL QUESTIONS

How do I activate my new Mallya^D2® ?

You must first charge Mallya^D2® using the USB cable provided in the box. Once plugged in, check that the LED turns blue. Allow the battery to charge for at least ten minutes, then disconnect the USB cable and check that the LED is still blue. Then, you can assemble Mallya^D2® on your FlexTouch^® pen as described in Mallya^D2® instructions for use. You can now pair your Mallya^D2® to the partner smartphone application.

What should I do if Mallya^D2® light fades orange?

The battery is low. Plug in and leave to charge for about 2 hours for a full charge.

What is the condition of Mallya^D2® battery when I first turn it on?

When you turn on Mallya^D2® for the first time, plug it to its USB cable and put on charge for at least 10 minutes. You can then pair your Mallya^D2® for use.

A full battery charge takes about 2 hours.

Does Mallya^D2® warn me when its battery is low?

Yes, the LED lights in orange. You should connect Mallya^D2® with the supplied USB cable and leave it to charge for about 2 hours for optimal charging.

How often should I charge Mallya^D2® battery?

Mallya^D2® needs to be recharged every 2 weeks.

What is Mallya^D2® lifetime?

Two years.

How do I assemble my Mallya^D2® device to my FlexTouch® pen?

Mallya^D2® must be assembled on the injection button of your pen. Carefully follow the instructions for use to attach it.

Hold Mallya^D2® by the transparent body part and align its notch with the FlexTouch^® pen dose window.

Insert Mallya^D2® on the FlexTouch^® pen and then Push Mallya^D2® with the palm of your hand until it is fully inserted on the pen.

I mounted Mallya^D2® on my pen. The LED is off.

Remember to activate Mallya^D2® after mounting or transferring it to a new FlexTouch^® pen.

How does Mallya^D2® take into account check of flow?

As per FlexTouch^® pen instructions for use, injection up to 2 increments will be pre-tagged as priming, waiting 2 minutes for a therapy dose to be delivered. If the therapy dose is delivered within 2 minutes, the check of flow tag is assigned, if not the dose is recorded as therapy dose.

The dose injected is not recorded in the app.

If you are not certain that you injected your drug, do not repeat your injection.

Monitor your treatment as instructed by your doctor.

There is a discrepancy between the dose dialed and the recorded dose in the app.

Mallya^D2® dose recording accuracy is 99% ±1 increment which means that you may experience occasional increment variations between the injected dose and the recorded dose.

Do I have to remove Mallya^D2® from my FlexTouch^® pen after each injection?

No. For practical reasons, it is better to leave Mallya^D2® mounted on your pen.

Can I store Mallya^D2® in the fridge?

Yes, you can. Please follow the instructions for use of your pen for appropriate storage conditions.

My Mallya^D2® is dirty. How can I clean it?

Make sure Mallya^D2® is unplugged and not connected to the USB charging cable.

Wipe the external surfaces with a slightly damp lint-free cloth, being careful not to get the micro-USB port wet. If needed, a small amount of neutral detergent may be used. Dry surfaces with a soft cloth.

Is Mallya^D2® waterproof?

Mallya^D2® is not waterproof, never wet the micro-USB port.

Can I take it though security check at the airport?

Yes, you can.

I have connected my Bluetooth speaker. Can it interfere?

No, it can’t.

My Mallya^D2® has fallen. How do I know it still works properly?

If the device experiences an external mechanical impact (knocking, bumping, dropping, etc.) or excessive stress, this may cause malfunctioning of the device. In case of malfunctioning, do not use the device and continue your injection pen treatment. Please contact Novo Nordisk call center as identified in the instructions for use for technical support.

Can I leave my Mallya^D2® in the car when it’s hot / cold?

Mallya^D2® must be used and stored between +2°C and +35°C.

SECURITY AND CONFIDENTIALITY

Is my data secure when I use Mallya^D2®?

Mallya^D2® incorporates appropriate technical security measures to maintain the security and confidentiality of the collected data stored in the internal memory of the Mallya^D2® device and to prevent it from being distorted, damaged, disclosed and accessed by unauthorized third parties . For data retrieved by authorized third parties app, please refer to application.

How long is the data kept by Mallya^D2®?

Mallya^D2® stores the last 100 injections (including check of flow).

All data collected in Mallya^D2® internal memory is erased by resetting it.

MOBILE APPLICATION

Where can I find the list of apps compatible with Mallya^D2®?

A list of compatible apps is available on Mallya website: https://my-mallya.com/en/find-your-application/

How to pair Mallya^D® with the app?

Pairing a Mallya^D2® is done from the app, not from the phone Bluetooth settings. After downloading the app, simply activate Bluetooth on your phone, and pair the Mallya^D2® with your smartphone following the app instructions to pair.

When and how is Mallya^D2® synchronized with the app?

As soon as Mallya^D2® is in the vicinity of your phone, the data will be fed back into the app, if it is properly launched and Bluetooth is enabled on your smartphone.

You don’t have to have your phone along when you inject, the synchronization can happen later and automatically.

Does Mallya^D2® need to be connected to the app when I make an injection?

You do not have to be connected to the application when you make an injection. Mallya^D2® records the data without being logged in. When you want to upload the data back to the app, you don’t have to do anything, just put the Mallya^D2® device close to your smartphone: if Bluetooth is enabled on your phone, and your app is launched, synchronization will happen.

Can I use Mallya^D2® on two or more compatible apps?

You cannot use several applications at the same time. During the pairing phase, a secure connection is created between Mallya^D2® and the application, preventing it from pairing with another application for data security (personal and health) reasons. If you wish to pair Mallya^D2®® with another application, you will need to reset it.

Can I pair Mallya^D2® with the app when my phone is not connected to the Internet?

You can pair Mallya^D2® with the App when the phone is not connected to the Internet, simply activate Bluetooth.