Safety Alert: Insulin Leakage Risk
The Medicines & Healthcare products Regulatory Agency (MHRA) has issued a safety alert regarding the risk of insulin leakage from the NovoRapid PumpCart prefilled insulin cartridge in the Roche Accu-Chek Insight Insulin pump, which can cause hyperglycaemia and diabetic ketoacidosis.
The main reasons for the leakages are the adapter needle being inserted at an incorrect angle and cracked cartridges, including non-visible hairline cracks.
Actions Required
Healthcare institutions must identify affected devices, contact users, and undertake a patient-centred risk assessment to determine suitability to move onto an alternative pump.
Patients can continue to use affected devices if there is a lack of suitable alternative insulin therapy or if deemed necessary after a patient-centred consultation.
Manual:
Download: Roche Accu-Chek Insight Insulin Pump User Manual
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