Field Safety Notice - Medtronic MiniMed™ Insulin Pump (Medtronic ref.: FA1446)

Medtronic MiniMed™ Paradigm™, MiniMed™ 600 series & MiniMed™ 700 series insulin pumps

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

The device manufacturer, Medtronic, recently found that changes in air pressure (e.g. in 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 flight take-off);
• Hyperglycaemia, when the air pressure increases, which could cause less insulin to be delivered (for example, during landing).

The recommended actions for users of the insulin pumps in question can be found in the Field Safety Notice intended for patients. These recommendations include:

• Checking 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.
• Discussing how to prepare for such situations with their healthcare professional. Patients should keep an emergency kit on them at all times, containing rapid-acting glucose and a backup insulin therapy.
• Paying attention to alerts from their insulin pump and to symptoms of hypoglycaemia or hyperglycaemia.

Insulin pump models concerned

Please refer to the table below.

Action to take

Healthcare professionals must:

• Send existing patients the manufacturer's patient letter (FA1446 Pump User Letter FR for LUX (Pdf, 154 Kb))
• Inform their new patients of the existence of this letter and explain to them the importance of monitoring their glucose levels frequently in situations of rapidly changing air pressure (such as when flying) so they can be prepared to treat hypoglycaemia or hyperglycaemia.

Distributors must:

• Send existing patients the manufacturer's patient letter (FA1446 Pump User Letter FR for LUX (Pdf, 154 Kb))
• Enclose the manufacturer's patient letter (FA1446 Pump User Letter FR for LUX (Pdf, 154 Kb)) with all future shipments of the devices concerned. 

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.