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MHRA issues Key Lock warning about Accu-Chek Insight insulin pump system

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a second warning in less than three weeks about the Accu-Chek Insight insulin pump systems.
Last month, the MHRA cautioned that NovoRapid PumpCart cartridge users could have an increased risk of hyperglycemia.
Now, the agency has warned that the Accu-Chek Insight, manufactured by Roche Diabetes Care, could over- or under-infuse insulin.
This is because of inadequately detailed handling instructions of the “Key Lock” function of the pump, which could lead to unintentional operation.
Over- or under-infusion of insulin could result in diabetes patients experiencing fluctuations in blood sugar levels, which could cause rapid deterioration of health.
Over-infusion could lead to low blood sugar levels, known as hypoglycemia, while under-infusion could cause diabetic ketoacidosis (DKA), a dangerous short-term complication that develops when blood sugar levels rise dangerously high. DKA should be treated as a medical emergency.
Diabetes departments and healthcare professionals responsible for patients using the device have been told to identify all users of the Accu-Chek Insight. The, patients should be advised to ensure that the Quick Bolus keys on the top of the insulin pump are not locked by the Key Lock function.
Furthermore, patients and carers should receive a copy of Roche’s Field Safety Notice, which should state the enhanced handling instructions.
If you have any questions about your Accu-Chek Insight insulin pump system, you should contact your doctor or a member of your diabetes care team.
You can also contact the manufacturer on 0800 731 2291.

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