MHRA warning: Accu-Chek Insight pump and leaking cartridges
People with diabetes using an Accu-Chek Insight and pre-filled insulin cartridges should insert their cartridges correctly to avoid them leaking and potentially giving an under-delivery of insulin. This can lead to high blood glucose (hyperglycaemia) with serious health implications.
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued this advice after feedback to the manufacturer, Roche Diabetes Care, from people who were experiencing leaking insulin cartridges.
Users of Accu-Chek Insight insulin pump system with NovoRapid PumpCart cartridges, can check for any leaked insulin in the cartridge compartment by regularly checking the pump a few hours after changing the cartridge as any leaked insulin would be visible.
The MHRA’s Director of Medical Devices, said: “It’s important that cartridges are correctly inserted into these pumps to ensure you receive the correct level of insulin. You should take care when changing cartridges to make sure they do not leak, reducing the amount of insulin being delivered.”
This warning from the MHRA was issued on August 16th 2016 although several weeks before, one of our members reported having had this experience twice and on the last occasion she had to be admitted to hospital with diabetic ketoacidosis.
If you experience this problem, you should report it to the MHRA via the Yellow Card Scheme as follows:
Email: [email protected] Tel: 0808 100 3352 or write to: Yellow Card Scheme, MHRA, 4.M, 151 Buckingham Palace Road, London SW1W 9SZ
MHRA issues warning about Accu-Chek Insight insulin pump
The Medicines and Healthcare Products Regulatory Agency (MHRA) has today advised people with diabetes that some pumps could give a maintenance message which can be misinterpreted and lead to incorrect use.
The only affected pump system, made by Roche, is the Accu-Chek Insight.
The MHRA warn that there is a risk of a hypoglycaemic event if users misinterpret maintenance message ‘M-83 pump not able to complete task’. Users are advised to check pump history before re-initiating a programmed task, such as bolus delivery.
They advise that all users should receive and acknowledge a field service notice available at https://mhra.filecamp.com/public/file/2ct3-57n6m0pd
Roche previously issued a field service notice about the issue in March, but has not received enough acknowledgements to confirm that healthcare professionals and users have received and acted on the instructions.