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Urgent field safety notice - SB_RDC_2015_05
YOUR ACTION REQUIRED
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Important information on the Accu-Chek® Insight insulin pump system:
Update of the handling instructions regarding the Key Lock function
Dear Mr Chapman,
We have recently received feedback from people with diabetes using the Accu-Chek Insight system, that they experienced an accidental unlocking of the pump keys and an unintentional operation of the system. We immediately investigated this feedback and identified the handling instructions and user manual of the Accu-Chek Insight insulin pump to be not detailed detailed enough regarding the description of the Key Lock function. This could potentially be misinterpreted or lead to unintentional, accidental operation of the pump. Such unintentional operation could potentially result in an under- or overdose of insulin and lead to severe health consequences, e.g. hyper- or hypoglycaemia.
As patient safety is our top priority, Roche Diabetes Care has enhanced the handling instructions for the Accu-Chek Insight system with immediate effect. In doing so, we aim to ensure that every user of the Accu-Chek Insight insulin pump knows how to operate and wear the system appropriately. These measures will help reduce the risk of an unintentional activation of the pump or accidental insulin delivery.
Important Information
Ensure the pump does not come into contact with other objects in the pocket such as keys, coins or phones. Such objects could damage the pump or accidentally press the Quick Bolus keys or the keys on the front of the pump. This could potentially result in an unintentional bolus delivery or unlocking of the pump. Such an accidental operation of the system can be detected by the vibration or acoustic alarm of the pump.
Please be aware that the Key Lock function of the Accu-Chek Insight insulin pump locks only the buttons on the front of the insulin pump.
The Quick Bolus keys on the top of the Accu-Chek Insight insulin pump are not locked by the Key Lock function. To activate the Quick Bolus function, one of the keys needs to be pressed for more than 3 seconds. The Quick Bolus keys are designed to enable an immediate bolus delivery. These keys can also be used to cancel a bolus in any situation.
Please be aware that the automatic Key Lock function of the pump is set to lock 30 seconds after the last key was pressed. This timeframe can be changed based on your individual needs from 4 to 60 seconds.
Recommendations for appropriate wearing and operation of the pump:
Please wear the pump in such a way that the Quick Bolus keys on the top of the pump cannot be pressed accidentally, in particular when carrying the pump in a pocket or wearing it under clothing (e.g. do not wear it in a pocket together with a car key, coins or other objects).
Please ensure that the pump keys on the front of the pump cannot be pressed accidentally. During the night while you are asleep, you may want to wear your pump in a protective case.
Please make sure to adjust the timeout interval for the Key Lock function to your 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.
Parents and caregivers should advise children not to press any pump keys, unless a pump operation is required, to avoid any unintentional operation of the pump.
For children and adolescents using the the Accu-Chek Insight system or users who are concerned that they may activate the Quick Bolus function unintentionally, we recommend setting the Quick Bolus increment to the minimum, i.e. 0.10 units.
The instructions provided in this letter will support you in the correct, reliable and satisfactory use of the Accu-Chek Insight insulin pump system. We sincerely apologise for any inconvenience this issue may have caused you.
Your national competent authority and healthcare professionals have been informed about this field action.
Thank you in advance for your understanding and co-operation. If you need any additional advice on the operation and wearing of the Accu-Chek Insight system or have any further questions, please do not hesitate to contact our Accu-Chek Customer Care line on 0800 731 2291 or email
[email protected]
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Kind regards,
Roche Diabetes Care
