Medical alert issued after reports of insulin leakage from insulin pump cartridges
Affected patients advised to use alternative insulin pumps where possible.
The Medical and Healthcare products Regulatory Agency (MHRA) has issued a National Patient Safety Alert following serious reports of serious harm associated with insulin leakage of a particular insulin pump.
The alert follows report of leakage during use of the Accu-Chek Insight Insulin pump with NovoRapid PumpCart prefilled insulin cartridges.
Patients using this device are recommended to be moved onto alternative insulin pumps where possible.
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.
A statement from MHRA said: “We have received reports of patient harm associated with leakage and over the past three 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 (caused by a lack of insulin).
“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.”
Insulin pumps (pictured) are a common treatment method for people living with diabetes.
The MHRA recommendation to treat people affected said: “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.”
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