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MHRA issue - Accu-Chek Insight insulin pump; risk of over or under infusion of insulin

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The Medicines and Healthcare Products Regulatory Agency (MHRA) has advised that all users of the Accu-chek Insight insulin pump system should make sure they receive a copy of the manufacturers field safety notice (FSN) by their pump provider or diabetes healthcare specialist.

The Quick Bolus keys on top of the pump are not locked by the Key Lock feature

The pump, manufactured by Roche Diabetes Care, has inadequate handling instructions of the 'key lock' feature. Patients and carers are not always aware that the Quick Bolus keys on top of the pump are not locked by the Key Lock feature which could result in rapid and severe deterioration of health e.g. hypoglycaemia or diabetic ketoacidosis.

Libby Dowling, Senior Clinical Advisor, said: "It's important that users of the Accu-Chek Insight insulin pump know that the Key Lock function only locks the buttons on the front of the device and not the Quick Bolus keys on the top of the pump. Not understanding how the key lock function works could mean an over or under dose of insulin, which could lead to devastating hypo or hyperglycaemia. So, it's important everyone with an Accu-Chek Insight pump understands fully how to use all of its features and functions and also receives a field safely notice."

If you are unsure about how to use this device or have not been given an FSN, please contact your healthcare professional immediately.

For any further questions, contact Roche's Accu-Chek Pump Careline on 0800 731 2291 or email to Burgesshill.insulinpumps@roche.com.

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