A Medical Device Alert has been issued with the Medicines and Healthcare products Regulatory Agency (MHRA) for the Accu-Chek Insight insulin pump system using NovoRapid PumpCart cartridges which is reportedly prone to leakage.
Leakage of the devices, manufactured by Roche Diabetes Care, could lead to serious consequences for users, which could include hyperglycaemia, diabetic ketoacidosis, or even death.
The leakages may result in an under-delivery of vital insulin for users, which can lead to serious health conditions that can rapidly evolve. This has stemmed for the cartridges being liable to incorrect insertion, and off the back of the alert, manuals are being updated, and users are being asked to take care when replacing cartridges, and check for leakages.
A serious concern
Any Medical Device Alert which puts user’s health at risk is always a serious concern.
An under-delivery of vital insulin for diabetic patients can lead to health complications arising very quickly, so the problem is a serious concern. Healthcare workers responsible for patients, as well as diabetes departments, are also to take action in ensuring that patients are made aware of the problem, and prevent any health complications arising.
Patients are to be made aware of the problem as quickly as possible
What happens if a patient suffers as a result of the problem?
The problem appears to be an unforeseen error that has possibly not been addressed in training and manuals as thoroughly as it ought to have been. If there is a large enough lack of understanding for users that this could happen, we have to question whether the delivery system is safe enough, and whether the manuals and guides are robust enough.
In a situation where a device can cause problems which can be entirely preventable through innovation or training, a patient who is adversely affected may have a right to claim compensation for any suffering caused. When we’re talking about something a serious as an insulin under-delivery – which in the worse case scenario can lead to patient death – it has to be looked at carefully.
Have you been affected?
If you have been affected then our Group Action Lawyers would be happy to speak with you to see what rights you may have if you have suffered as a result of the problem. Please don’t hesitate to contact us for free, friendly, informal, and no obligation advice.