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MHRA Alert: Paradigm ambulatory insulin infusion pumps, manufactured by Medtronic

Medtronic have identified a risk of compromised insulin therapy when using Paradigm ambulatory insulin infusion pumps, which may lead to severe hypoglycaemia (low blood glucose) or severe hyperglycaemia (high blood glucose).

The affected models are: MMT - 511, 512, 712, 712E, 515, 715, 522, 722, 722K, 523, 723, 723K, 554 (VEO) and 754 (VEO).

The root causes are:

1. Loose drive support cap (all models)

The pump is designed to withstand occasional drops or bumps; however, when this happens it is recommended to check the pump for cracks or damage. The pump’s drive support cap holds the pump motor in place and allows the motor’s piston to press against the reservoir to deliver insulin.

In rare cases, the cap may stick out from the bottom of the reservoir compartment. This condition can occur when the pump is damaged due to impact with a hard surface (for example if it is dropped). If the loose drive support cap is pressed on it could result in the unintended delivery of additional insulin.

Recommendations

  • Regularly examine your pump, especially after a shock or drop on a hard surface.
  • Discontinue pump use if drive support cap is loose; do not press on this portion of the pump; and contact the manufacturer.

2. Damage to pump if immersed in water (all models)

As explained in the pump user guide, exposure to water may result in pump alarm, damage of the pump’s internal electronics, or cause the buttons to stop working.

To swim or participate in other water activities, always disconnect from your Paradigm pump, and reconnect after water play.

If you accidentally submerge your insulin 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 insulin pump's Utilities Menu. If you believe that water has entered your insulin pump or you observe any other possible insulin pump malfunction, please check your blood glucose, treat high blood glucose (if necessary) with an injection and contact your help line or representative for further assistance.

Recommendations

  • Do not immerse the pump in water.

3. Programming issue related to the sensor graph timeout (Paradigm VEO MMT-554 and MMT-754 only).

This information applies only topump users who are also using Medtronic Continuous Glucose Monitoring and have the Low Glucose Suspend feature enabled.

Your Paradigm VEO insulin pump allows you to set the number of minutes to display the Sensor Graph before returning to the home screen.

The factory default setting for Sensor Graph timeout is set to two minutes. If the Sensor Graph timeout is set to “NONE” it can prevent the auto-resume of basal delivery two hours after a Low Glucose Suspend event, which can result in elevated blood glucose values.

This will only happen if you go to the Sensor Graph screen during a Low Glucose Suspend event, and leave that screen displayed. When this happens, the pump will beep three times every 15 minutes to remind you that insulin delivery has been suspended. All other alarms will function normally, but basal delivery will not resume as long as the Sensor Graph screen is displayed.

Recommendations

For Paradigm VEO models:

  • 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,” please follow the steps below to reset it now:
    1. Go to the Sensor Menu
    2. Select Edit Settings, Press ACT
    3. Select Graph Time Out, Press ACT
    4. Select 2, 4 or 6 minutes (do not select “NONE”), Press ACT

Further information

If you are affected by this or unsure of what to do, speak to a member of your diabetes healthcare team.

Contact Medtronic

Medtronic LtdLezlie BridgeTel: 01923 212 213Email:lezlie.j.bridge@medtronic.com

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