Roche Accu-Chek Insight Training Chart

Consumer Letter
(Accu-Chek Insight PFC)
Urgent field safety notice
<Enter address here>
Location, Date
Important information on the Accu-Chek® Insight insulin pump system:
Update of the handling instructions for changing an insulin cartridge
Dear Customer [please personalize],
We have seen an increase in customer feedback from people with diabetes using the Accu-Chek Insight
insulin pump system and experiencing leaking insulin cartridges. We have immediately investigated this
feedback and identified the need to update the handling instructions and user manual of the Accu-Chek
Insight insulin pump for inserting or changing the pre-filled insulin cartridge. If inserted incorrectly,
insulin can leak from the cartridge into the cartridge compartment resulting in an under-delivery of
insulin which can lead to complications as e.g. a hyperglycemia. Such a leaking cartridge can be
detected by regularly checking the pump a few hours following the cartridge change as the insulin
would be visible e.g. through condensation in the pump's cartridge compartment. To avoid the risk of
leaking insulin, please make sure that you always follow the handling steps described below
and in the attached training chart when inserting or changing a pre-filled insulin cartridge.
As patient safety is our key priority, we have started to update and enhance our handling instructions
with immediate effect and we will provide an updated user manual at a later stage. In doing so, we aim
to ensure that every user of the Accu-Chek Insight insulin pump knows how to insert or change the
insulin cartridge correctly. These measures will help reduce the risk of insulin leaking from the cartridge.
As the handling differs from other Accu-Chek insulin pump systems, we would like to draw your
particular attention to this and have also started to re-emphasise these specific handling steps with
healthcare providers. It is important that whenever you change the insulin cartridge of your
Accu-Chek Insight system you follow the steps as they are described in the attached training
chart.
Please make sure that
1.
you always check the cartridge, including the rubber plunger at the bottom of the cartridge. Do
not use it if any damage or leakage is seen or if the rubber plunger has been drawn above the
white label band at the bottom of the cartridge. This could be a result of leakage of insulin. If you
suspect the cartridge is damaged, take it back to your supplier. Do not use the insulin cartridge
if the cartridge or the device containing the cartridge is dropped, damaged or crushed.
2.
you always hold the pump in an upright position when inserting the new cartridge as
shown in the attached training chart.
3. every time you change your cartridge, you should also change your adapter and tube.
4.
you place a new adapter on the bayonet socket of the cartridge compartment. Make sure you
insert the nose of the adapter into the notches of the pump's housing at a right angle (90°).
Otherwise the needle located in the nose of the adapter could bend and lead to leakage of
insulin into the cartridge compartment.