People with diabetes using the Accu-Chek Insight insulin pump system should check how they operate and wear the medical device to reduce the risk of an unwanted dose of insulin.
This could lead to not enough glucose in the bloodstream (hypoglycaemia) and cause a severe deterioration of health. If the person is unsure if insulin has been delivered and does not deliver a dose there is the risk of a potentially life-threatening complication of diabetes caused by too little insulin in the body (diabetic ketoacidosis).
The manufacturer, Roche Diabetes Care, has now improved the handling instructions for the medical device.
If patients are unsure whether or not they have injected insulin they can review their pump history and contact the Roche helpline if there are any queries on 0800 731 2291.
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued advice to healthcare professionals on handling this issue following reports from people who experienced health problems after receiving an accidental insulin dose because the Quick Bolus pump keys do not lock.
People are reminded that the ‘Key Lock’ function on the Accu-Chek Insight pump locks only the buttons on the front of the insulin pump. Care should therefore be taken to ensure that the Quick Bolus keys on the top of the pump that deliver a dose of insulin are not pressed accidentally, for example when sleeping.
People should ensure the pump does not come into contact with other objects in the pocket such as keys, coins or phones. These items could damage the pump or accidentally press the Quick Bolus keys or the keys on the front of the pump. The pump sounds an alarm or vibrates when accidentally operated.
People are advised to take precautions to ensure the pump keys on the front are not pressed accidently, which can include wearing the pump in a protective case when sleeping.
Parents and caregivers should tell children not to press any pump keys unless a pump operation is required, to avoid any unintentional operation of the pump.
People should adjust the timeout interval for the Key Lock function to their individual needs. For children, it is recommended to use the minimum timeout interval of 4 seconds. This means that the pump will automatically lock itself 4 seconds after an accidental unlocking, if no other key has been pressed in the meantime.
John Wilkinson, MHRA’s Director of Medical Devices, said:
It’s important that you follow the instructions for your insulin pump carefully to ensure you receive the correct level of insulin.
You should take care when operating and locking your insulin pump to make sure you do not accidentally activate the pump as this could lead to an unwanted dose of insulin.
We continue to encourage people to report any issues involving medical devices to MHRA via our Yellow Card Scheme.
For additional advice or training on the operation and wearing of the Accu-Chek Insight system people are encouraged to contact the Accu-Chek Customer Care line on 0800 731 2291 or email firstname.lastname@example.org.
Notes to Editor
- Please see the link to the Medical Device Alert.
- See the Field Safety Notice (FSN)
Please find the link to the Yellow Card Scheme.
- MHRA is responsible for regulating all medicines and medical devices in the UK. All our work is underpinned by robust and fact-based judgments to ensure that the benefits justify any risks. MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). The Agency is an executive agency of the Department of Health. www.mhra.gov.uk