The UK is warning of a risk of incorrect insulin dosage caused by leaking cartridges used with Roche’s Accu-Check Insight insulin pump system.
The Medicines and Healthcare products Regulatory Agency said that cartridges inserted incorrectly can leak insulin, resulting in under-delivery of insulin, which could lead to rapid deterioration of health, diabetic ketoacidosis or death.
Roche released an urgent Field Safety Notice detailing the problem and offered advice and additional training on the use of the device.
Leaking cartridges can be detected by regularly checking the pump a few hours following the cartridge change as the insulin would be visible through condensation in the pump’s cartridge compartment, the company said in the field alert.
Roche said it is updating its handling instructions immediately and will provide updated user manuals shortly at a later stage. In the meantime, users should: