Consumers and health professionals are advised that Medtronic, in consultation with the TGA, has issued a safety advisory to reinforce awareness of the need to confirm insulin dosage when using certain Medtronic Paradigm insulin pump models due to the risk of over-infusion.
Medtronic Paradigm insulin pumps are portable devices used to help control insulin-dependent diabetes.
A Medtronic paradigm insulin pump
Under some circumstances users can accidentally program the devices to deliver more insulin than required, potentially leading to hypoglycaemia.
Medtronic Paradigm insulin pumps maintain a patients blood glucose targets in two ways, by delivering:
- a continuous, minimal dose of insulin ('basal' mode)
- a larger dose of insulin when required ('bolus' mode).
Medtronic has advised it had received a small number of reports regarding users who have accidentally programmed the pump to deliver the maximum amount in bolus mode, including one incident that resulted in severe hypoglycaemia. The TGA has received one Australian report where the issue led to a patient being hospitalised.
This issue can occur when users program the device through the main menu which allows them to scroll through the insulin dose settings. When setting the amount through the main menu in either bolus or basal mode, a single press of the down arrow scrolls from 0.0 units to the programmed maximum insulin dose. The image below shows this demonstrated in bolus mode.
The issue does not occur when the 'Express Bolus' button () is used, as scrolling using the down arrow stops at 0.0 units while using this mode.
Because accidental button pressing errors may occur, it is important that users always confirm that the insulin dose flashing on the display is correct before pressing the 'ACT' button to start delivery.
Affected Medtronic Paradigm insulin pump models are:
Information for consumers
If you have a Medtronic Paradigm Insulin Pump, you should have received a letter from Medtronic with information about this matter and how to program the safety settings on your pump to minimise the risk of an accidental over-infusion of insulin.
To avoid this issue consumers should:
- pay close attention when programming insulin doses through the main menu, because scrolling down allows the dose displayed on the screen to go from 0.0 units to the maximum programmed insulin dose
- always confirm the insulin dose that is flashing on the display is correct before pressing 'ACT' to start delivery
- make sure your 'Max Bolus' and 'Max Basal' settings are programmed according to your personal insulin needs, per your health professional's instructions.
If you have any questions or concerns, contact Medtronics 24-hour helpline on 1800 777 808 (option 1). Alternatively, you can speak to your diabetes nurse educator or other health professional.
Information for all health professionals
Health professionals who are treating patients with a Medtronic Paradigm insulin pump should have received a letter from Medtronic advising them of this matter and the information provided to users.
Advise patients and caregivers:
- to pay close attention when programming insulin doses through the main menu as scrolling down allows the dose displayed on the screen to go from 0.0 units to the maximum programmed insulin dose
- to always confirm the insulin dose that is flashing on the display is correct before pressing 'ACT' to start delivery
- of their recommended maximum and minimum insulin settings and to ensure their device is programmed with these settings.
If you or a patient using a Medtronic Paradigm Insulin Pump has any more questions or concerns about this matter contact Medtronics 24-hour helpline on 1800 777 808 (choose option 1).
Medtronic's User Guide for instructions on how to program the maximum and minimum insulin delivery settings can be found on the company's website.
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individuals 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.