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.
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 2/2
Approved according to SOP 04.07.07! The Signature will not be printed! TW IPM Accu-Chek Insight Training Chart New handling instructions for changing a cartridge w Needle 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). 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. Step 1: How to remove an empty cartridge 1 2 3 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. 4 5 6 120 The Change cartridge screen appears. Hold the pump in an upright position. Turn the adapter with the tubing anticlockwise. When you reach an angle of about 120, remove the adapter with the cartridge. 7 8 9 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.
Note 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. Step 2: How to insert a new cartridge Ensure the cartridge and insulin are at room temperature. 10 CORRECT INCORRECT 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. 11 CORRECT INCORRECT 90 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. 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. 12 13 14 120 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. 15 16 17 You are prompted to disconnect the infusion set from your body. Press o to confirm. Last update: 2016-05 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
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: +44 (0)1444 256 205 or email to: burgesshill.dcsafety@roche.com 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.