Roche Accu-Chek Insight User manual

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.

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5. you turn the adapter clockwise all the way until it stops. The adapter is correctly positioned
when it is aligned with the pump’s housing.
The enhanced instructions provided with this letter aim to support you in the correct, reliable and
satisfactory use of your Accu-Chek Insight insulin pump system. Please keep these instructions in
easy reach until you receive the updated user manual for your Accu-Chek Insight system. Your
national competent authority, healthcare professionals, distributors and retailers 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 at xxx-xxx-xxx at any time.
Kind regards,
Roche Diabetes Care
ATTACHMENT: Accu-Chek® Insight Training Chart

120°
Accu-Chek Insight Training Chart
 Always disconnect the infusion set from your body before
changing the cartridge.
 Always use a new adapter when changing the cartridge.
 A needle is located in the centre of the adapter nose.
Insulin delivery is only guaranteed if the needle is fitted
onto the cartridge centrally in a perpendicular manner
(see step 11).
Step 1: How to remove an empty cartridge
From the Status screen, press o. The main Menu appears.
Press z to move to Cartridge and infusion set.
Press o to select.
The Cartridge and infusion set menu appears.
Press o to select Change cartridge.
The Change cartridge screen appears. Hold the pump in an upright position.
Turn the adapter with the tubing anti-
clockwise.
When you reach an angle of about 120°,
remove the adapter with the cartridge.
 If an empty cartridge is inserted into the pump (e.g. for
training purposes), the pump displays the programmed
insulin deliveries (infusion set priming, basal rate and
bolus deliveries), even though no insulin is being delivered
due to the empty cartridge.
 Selecting the wrong cartridge type can lead to
underdelivery or overdelivery of insulin.
Needle
Important: Press o to confirm that you have
removed the adapter and the cartridge. The
pump automatically starts rewinding the piston
rod.
You may damage your pump or
cartridge if the piston rod is not
rewound.
When the pump finishes rewinding, you are
prompted to insert the new cartridge and
connect the adapter.
Only insert a new cartridge if the Insert
new cartridge and connect adapter
screen appears.
TW
IPM
Approved according to „SOP 04.07.07“!
The Signature will not be printed!
New handling instructions for changing a cartridge
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schottg1 - Mai 18, 2016
marina4 - May 18, 2016

120°
Step 2: How to insert a new cartridge
Make sure you hold the pump in an upright
position.
Insert the cartridge – plunger first – into the
cartridge compartment.
Make sure that the cartridge fits correctly. If the
cartridge does not fit as shown, check steps
1 to 7.
Do not push the cartridge into the pump if the
cartridge is sticking out. This may damage the
pump or the cartridge.
Make sure that the piston rod has rewound
completely. If the piston rod has not rewound
completely, contact your local pump support.
CORRECT
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 could bend.
90°
CORRECT
Place the adapter on the bayonet socket of the
cartridge compartment only as described in
step 11.
Do not place the adapter on the bayonet socket
of the cartridge compartment if the adapter is
not positioned as described in step 11.
Turn the adapter clockwise all the way until it
stops. The adapter is correctly positioned when
it is aligned with the pump’s housing.
Then press o to confirm.
The Cartridge type screen appears.
Press x or z to move to the appropriate
cartridge type.
Press o to select.
INCORRECT
INCORRECT
You are prompted to disconnect the infusion set
from your body.
Press o to confirm.
The pump detects the position of the plunger in
the cartridge.
The pump then performs a self-test. After the self-test, the pump returns to the
Cartridge and infusion set menu. Fill tubing is
selected by default.
ACCU-CHEK and ACCU-CHEK INSIGHT are trademarks of Roche.
© 2016 Roche Diabetes Care
Roche Diabetes Care GmbH
Sandhofer Strasse 116
68305 Mannheim, Germany
www.accu-chek.com
Last update: 2016-05
Ensure the cartridge and insulin are at room temperature.
 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 insulin pump containing the
cartridge is dropped, damaged or crushed.
Note
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URGENT FIELD SAFETY NOTICE
Roche Diabetes Care Ref.: SB_RDC_2016_07
Accu-Chek®Insight insulin pump
Acknowledgement Form / Faxback
Please submit this acknowledgement form to Roche Diabetes Care;
•via postal address: IDS Team, Roche Diabetes Care Limited , Charles Avenue , Burgess Hill ,
West Sussex, RH15 9RY
•or via fax: [phone]
•or email to: [e-mail]
•via your Roche Infusion Sales Specialist
Herewith I acknowledge that I have received the Field Safety Notice of xx. Jun.2016 associated with
the updating of the handling instructions regarding the change of the pre-filled cartridge at the
Accu-Chek®Insight insulin pump.
Name / title of person completing this form:
……………………………………………………………...
Name of Organisation:
……………………………………………………………………………………………………
Phone:…………………………………. Email:…………………………………………………………….
Address:……………………………………………………………………………………………………...
………………………………………………………………………………………………………………..
Date: …………………………………….. Signature………………………………………………………
Thank you for your assistance with this Field Safety Corrective Action.