Roche updating Accu-Chek manual after reports of insulin leaks and under dosing
The UK Medicines and Healthcare products Regulatory Agency (MHRA) stressed the importance of using the Accu-Chek Insight insulin pump system and the NovoRapid PumpCart cartridges correctly in a note published on Tuesday
The UK agency said it had decided to issue the advice after some diabetic users reported leaking insulin cartridges to Roche.
This was confirmed by a spokeswoman for the Swiss pharmaceutical firm who told us “users reported that they experienced insulin leaking into the pump’s cartridge compartment in rare cases resulting in an under delivery of insulin. Some users reported hyperglycemic symptoms.”
She added that: “The complaint rate of this issue has been approx. 0.015% however as patient safety is of critical importance to us, we have initiated this field safety corrective action together with the competent authorities.”
Response
Roche is in the process of updating the handling instructions and user manual of the Accu-Chek Insight insulin pump for inserting or changing the pre-filled insulin cartridge.
Accu-Chek is made at Roche’s facility in Vienna, Austria. The NovoRapid is supplied by NovoNordisk.
Roche is in the process of updating the handling instructions and user manual of the Accu-Chek Insight insulin pump for inserting or changing the pre-filled insulin cartridge.
The spokeswoman added that: “We are currently evaluating a number of technical options to significantly reduce the likelihood that a patient inserts an insulin cartridge incorrectly, potentially leading to insulin leakage due to a handling error.”
