Safety notice - Medtronic MiniMed™, Paradigm™, MiniMed™ 600/700 series insulin pump systems

Pump Delivery Volume Accuracy (DVA) during changes in air pressure

The device manufacturer, Medtronic, recently found that changes in air pressure (e.g. aboard aircraft) can cause the unintended release of insulin when certain MiniMed™ Paradigm™, MiniMed™ 600 series & MiniMed 700 series insulin pumps are being used by diabetic patients. If this occurs, there is a low risk of patients developing:

• Hypoglycaemia, when the air pressure decreases, which could cause more insulin to be delivered (for example, during take-off);
• Hyperglycaemia, when the air pressure increases, which could cause less insulin to be delivered (for example, during landing).

Insulin pump models affected

Please refer to the table below.

Action to take

• Check glucose levels frequently during activities such as air travel, amusement park rides, and other situations where sudden or extreme changes in air pressure, altitude or gravity may occur. 
  
• Discuss your situation with your doctor or a healthcare professional in order to be prepared for any issues. Patients should keep an emergency kit on them at all times, containing fast-acting glucose and a backup insulin injector.
• Pay attention to the alarms and warnings on your pump and to any potential symptoms of hypoglycaemia or hyperglycaemia.

For any other questions, please contact your medical device market surveillance authority – which, in Luxembourg, is the Division of Pharmacy and Medicines of the Health Directorate – by email to: meddevices.vigilance@ms.etat.lu.