GENERAL
QUESTIONS

Mallya® is a connected device compatible with the novo nordisk® FlexPro® pen injectors.
Mallya® records information about the dose, time and date of each injection and transmits it via Bluetooth to a mobile application.

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

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

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

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

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

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

TECHNICAL
QUESTIONS

You must first charge Mallya® 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® on your FlexPro® pen injector as described in Mallya® instructions for use. You can now pair your Mallya® to the partner smartphone application.
The battery is low. Plug in and leave to charge for about 2 hours for a full charge.

When you turn on Mallya® 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® for use.
A full battery charge takes about 2 hours.

Yes, the LED lights in orange. You should connect Mallya® with the supplied USB cable and leave it to charge for about 2 hours for optimal charging.
Mallya® needs to be recharged every 2 weeks.
Two years.

Mallya® must be assembled on the injection button of your FlexPro® pen injector. Carefully follow the instructions for use to attach it.
Hold Mallya® by the transparent body part and align its notch with the FlexPro® pen injector dose window.
Insert Mallya® on the FlexPro® pen injector and then Push Mallya® with the palm of your hand until it is fully inserted on the pen.

Remember to activate Mallya® after mounting or transferring it to a new FlexPro® pen injector.
As per FlexPro® pen injector instructions for use, injection up to 1 increment 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.

If you are not certain that you injected your drug, do not repeat your injection.
Monitor your treatment as instructed by your doctor.

Mallya® dose recording accuracy is 99% ±1 increment which means that you may experience occasional increment variations between the injected dose and the recorded dose.
No. For practical reasons, it is better to leave Mallya® mounted on your pen injector.
Yes, you can. Please follow the instructions for use of your FlexPro® pen injector for appropriate storage conditions.

Make sure Mallya® 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.

Mallya® is not waterproof, never wet the micro-USB port.
Yes, you can.
No, it can’t.
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.
Mallya® must be used and stored between +2°C and +35°C.

SECURITY
AND CONFIDENTIALITY

The collected data is stored in the internal memory of the Mallya® device.
Mallya® incorporates appropriate technical security measures to maintain the security and confidentiality of your data to prevent it from being distorted, damaged, disclosed and accessed by unauthorized third parties.

Only you have access to this data and can possibly decide to share it with a third party, be it a relative or a health professional; this functionality will depend on the partner smartphone application.

Mallya® stores the last 100 injections.
All data collected in Mallya® internal memory is erased by resetting it.

MOBILE
APPLICATION

A list of connectable apps is available on Mallya® website: https://my-mallya.com/
Pairing a Mallya® 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® with your smartphone following the app instructions to pair.

As soon as Mallya® is in the vicinity of your phone, the data can be fed back into the app, if it is properly launched and Bluetooth is enabled on your smartphone.
Follow the instructions in the app for data synchronization.
You don’t need to have your smartphone along when you inject, the synchronization can happen later.

You do not have to be connected to the application when you make an injection. Mallya® records the data without being logged in. When you want to upload the data back to the app, put Mallya® close to your smartphone and follow the instructions in the mobile application.
You cannot use several applications at the same time. During the pairing phase, a secure connection is created between Mallya® and the application, preventing it from pairing with another application for data security (personal and health) reasons. If you wish to pair Mallya® with another application, you will need to reset it.
You can pair Mallya® with the App when the phone is not connected to the Internet, simply activate Bluetooth.

Other

Please refer to the Mallya IFU available for download above the FAQ section.