A NovoRapid PumpCart insulin cartridge and Roche Accu-Chek Insight insulin pump safety warning has been issued.
The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a safety warning, following concerns raised about the NovoRapid PumpCart prefilled insulin cartridge and the Roche Accu-Chek Insight Insulin pump. This device, which releases the insulin your body needs throughout the day and night, comprises a pump, tube, battery and a pre-filled glass insulin cartridge. In some of the reported leakage incidents, 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, there were consequences of not receiving enough insulin from their pump system, including reports of severely high blood sugar and diabetic ketoacidosis.
The MHRA is advising healthcare professionals to contact patients who are affected by 26 November 2022 to discuss their individual needs, source an alternative pump where appropriate and give them further advice as needed.
Dr June Raine, Chief Executive, Medicines and Healthcare products Regulatory Agency said: “Because of the rare risk of insulin leakage from the Roche Accu-Chek Insight insulin pump, patients should check the pre-filled glass insulin cartridge for any cracks prior to usage. We would like to reassure patients that the risk of leakage remains low when used in accordance with instructions and today’s safety recommendations. Patients should continue to use their insulin pump as recommended whilst they await contact from their healthcare professional regarding an alternative device. If you suspect a problem with your insulin pump, please seek medical advice immediately.”
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