Roche Accu-Chek Insight insulin pump with NovoRapid PumpCart insulin cartridges: alert following cases of insulin leakage
We have issued a National Patient Safety Alert following serious reports of harm associated with insulin leakage during use of the Accu-Chek Insight Insulin pump with NovoRapid PumpCart prefilled insulin cartridges. Patients should be moved onto alternative insulin pumps where possible.
Advice for healthcare professionals:
- the Accu-Chek Insight Insulin pump used with NovoRapid PumpCart prefilled insulin cartridges has been associated with insulin leakage events, including cases of severe hyperglycaemia and diabetic ketoacidosis in UK patients
- follow the steps set out by your organisation to action the National Patient Safety Alert, including to identify and review patients using Roche Accu-Chek Insight insulin pumps and discuss moving them to an alternative insulin pumps where possible
- pharmacists should continue to dispense the NovoRapid PumpCart cartridges but ask patients whether they use the Accu-Chek Insight insulin pump and provide advice and education to minimise the risks (as below)
- report suspected adverse drug reactions or adverse incidents to the Yellow Card scheme
Advice for healthcare professionals to give to patients and carers:
- the MHRA has taken action following cases in which insulin has leaked from the glass cartridge in the Accu-Chek Insight insulin pump – some cases were associated with severely high blood sugar and diabetic ketoacidosis
- your healthcare professional team has been asked to discuss with you changing to another insulin pump where possible
- while you continue to use the Accu-Chek Insight Insulin pump:
- check the pump and cartridge regularly for damages, for example cracks or leakage. If you smell insulin (a strong antiseptic chemical smell) this could also indicate a leakage.
- follow the advice in the latest customer notice to replace previous designs for pump adaptors and tubing
- do not use the cartridge if cracks or leakage are seen or if the cartridge was dropped. Follow the instructions of your Accu-Chek Insight user manual for replacing a cartridge and for cleaning the cartridge compartment in the insulin pump.
- during the day and before going to sleep please carefully check that your insulin pump is delivering insulin and there are no leakages.
- never change treatment delivery methods without first consulting a relevant healthcare professional.
- failure of insulin delivery due to leakage may not result in an alert notification from the insulin pump and cracks and leakages may not always be visible. You should check blood glucose levels multiple times throughout your day while using pumps.
- tell your healthcare professional immediately if you suspect a problem with your insulin delivery.
Safety issue
The Roche Accu-Chek Insight insulin pump is a medical device used by insulin-dependent patients with diabetes to deliver insulin. The Accu-Chek Insight pump is used in combination with NovoRapid PumpCart cartridges, which contain insulin (as insulin aspart) in a glass cartridge.
We have received reports of patient harm associated with leakage and over the past 3 years we have kept this safety concern under close review. In some of the reported leakage incidents, the cartridges were found to be cracked and provided an inadequate supply of insulin to patients. However, leakages also occurred in cases where no cracks in the cartridge were visible.
In some patients, serious consequences resulted from an inadequate supply of insulin. We received 25 serious cases in both 2020 and 2021 (including cases where a patient required urgent medical treatment or hospitalisation) in association with an insulin leakage event in UK patients, including 18 cases and 17 cases respectively of diabetic ketoacidosis.
Despite actions from the manufacturer to reduce the incidence of these events, we continue to receive reports of insulin leakage and we have taken further action to protect patients.
Actions for the healthcare system
Healthcare professionals should inform patients who use the Accu-Chek Insight of the risk of leakage and the updated instructions to reduce risk. Where possible, patients should be moved onto alternative pumps in accordance with the actions in the National Patient Safety Alert.
A risk assessment must be recorded with all users of Accu-Chek Insight pumps. This should involve a discussion of the risks of continuing treatment with the affected device and consider the best interest of the patient and the management of their diabetes.
Patients who continue to use the Accu-Chek Insight pump should be instructed to follow the advice in the manufacturer’s latest Field Safety Notice. This includes using the new adapter and tubing. Users should also be instructed to inspect the pump and cartridges regularly for cracks or leaks, and to check blood glucose levels multiple times throughout the day. For the full recommendations to users, see the Field Safety Notice and our press release.
Roche Diabetes Care ceased marketing the Accu-Chek Insight pump in the UK at the end of 2021 and new patients will not be offered the pump. Therefore, all existing Accu-Chek Insight pump users will need to be transferred to an alternative pump at the end of their pump warranty, irrespective of the outcome of their risk assessment.
Report on a Yellow Card
Suspected adverse reactions or incidents associated with medicines or medical devices used in diabetes should be reported to the Yellow Card scheme.
Healthcare professionals, patients, and caregivers are asked to submit reports using the Yellow Card scheme electronically using:
- the Yellow Card website
- the Yellow Card app; download from the Apple App Store or Google Play Store
- some clinical IT systems for healthcare professionals (EMIS, SystmOne, Vision, MiDatabank, and Ulysses)
When reporting please provide as much information as possible, including information about batch numbers, medical history, any concomitant medication, onset timing, treatment dates, and product brand name.
Please note, any medical device incidents should be reported to Health Facilities Scotland in Scotland and to the Northern Ireland Adverse Incident Centre in Northern Ireland.
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Article citation: Drug Safety Update volume 15, issue 11: June 2022: 2.