Roche Accu-Chek Insight Quick Start Manual

Urgent field safety notice

SB_RDC_2015_05
Important information on the Accu-Chek® Insight insulin pump system:
Update of the handling instructions regarding the Key Lock function
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 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:
1. 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.
2.
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.
3. 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.
4. 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.