Medtronic paradigm insulin pump
10 April 2013
Health professionals and consumers are advised that Medtronic, in consultation with the TGA, has issued information regarding three potential but rare issues with its Medtronic Paradigm Insulin Pump.
Medtronic Paradigm Insulin Pumps are small, portable devices used for the control of insulin-dependent diabetes. They maintain a patient's blood glucose targets in two ways:
- by delivering a continuous, minimal dose of insulin (basal)
- by delivering a larger dose of insulin when required (bolus).
The affected model numbers are:
Details of the three potential issues identified with Medtronic Paradigm Insulin Pumps are provided below.
If you have a Medtronic Paradigm Insulin Pump, you should receive a letter from Medtronic with further information about the three potential issues and instructions for what you should do if you experience them. A summary of those issues and instructions are provided below.
Please note that these issues are rare and it is unlikely that you will need to replace your Medtronic Paradigm Insulin Pump.
If you have any questions or concerns, contact Medtronic's 24-hour helpline on 1800 777 808 (option 1).
The drive support cap holds the device's pump motor in place and allows the motor's piston to press against the reservoir to deliver insulin.
There have been reports of loose drive support caps and, in rare cases, the cap may stick out from the bottom of the reservoir compartment. This can happen if the device hits a hard surface, for example, if it is dropped.
In one report, the user tried to push the drive support cap back into place while they were still attached to it, which resulted in unintentional delivery of insulin and, consequently, severe hypoglycaemia.
Users are advised to regularly examine their Medtronic Paradigm Insulin Pumps. The device is designed to withstand occasional drops and bumps, but should be checked for any signs of damage if it has been dropped on a hard surface.
If you have a Medtronic Paradigm Insulin Pump and the drive support cap is sticking out:
- do not try to push it back in
- stop using the pump and manage your diabetes in accordance with the back-up plan established by your health professional
- contact Medtronic's 24-hour helpline on 1800 777 808 (option 1) to discuss further options including possible insulin pump replacement
- contact your health professional for further advice.
Please note, this information only applies to users who have a Paradigm VEO pump (model numbers MMT-554 and MMT-754), and only if they use Medtronic Continuous Glucose Monitoring and have the Low Glucose Suspend feature enabled.
Paradigm Veo insulin pumps allow the user to set the time to display the sensor graph before returning to the home screen. The default setting is 2 minutes.
If the sensor graph timeout is set to 'None', it can prevent the auto-resume of basal delivery until 2 hours after a Low Glucose Suspend event. This can result in increased blood glucose levels.
If this happens, the device will beep three times every 15 minutes, but basal delivery will not resume while the sensor graph screen is displayed.
Users are advised:
- do not change the sensor graph timeout setting to 'None'
- if you are using the Low Glucose Suspend feature and have changed the sensor graph timeout setting to 'None', reset Graph Time Out (selecting 2, 4 or 6 minutes).
As outlined in the device's user guide, exposure to water can damage the pump's internal electronics. The device is designed to withstand splashing or brief dunking, but should not be immersed in water.
Please note the below extracts from the device's user guide:
To swim or participate in other water activities, always disconnect from your pump, keep it in a safe place and reconnect after you are out of the water.
If you accidentally submerge your pump in water, dry the pump quickly using a soft, clean towel and verify that it is working properly by selecting Self-test from the pump's Utilities Menu.
Medtronic has sent letters to health professionals who are treating patients with a Medtronic Paradigm Insulin Pump, advising them of the three potential issues and of the information provided to users.
If a patient presents with a Medtronic Paradigm Insulin Pump that exhibits any of the identified issues, please advise them of the information provided for consumers in the above section.
Please note that these issues are rare and it is unlikely that patients will need to replace their Medtronic Paradigm Insulin Pump.
For further information, contact Medtronic's 24-hour helpline on 1800 777 808 (option 1).
Consumers and health professionals are encouraged to report problems with medical devices. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
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.
Content last updated: Wednesday, 10 April 2013
Web page last updated: Tuesday, 16 April 2013