The Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday issued a medical device alert for healthcare workers and diabetes departments on Accu-Chek Insight insulin pumps manufactured by Roche Diabetes Care.
The key lock function of the affected pumps (pumps with serial numbers below 32100000) lock only the buttons on the front of the insulin pump. It does not lock the quick bolus keys on the top.
So, some of the pumps need to be fitted with key frames to reduce the risk of accidentally unlocking keys or pressing the bolus buttons. Roche Diabetes Care issued important instruction on how to fit two separate key frames onto all affected pumps as they received reports of unintended boluses being delivered.
The Alert directs all relevant organisations to be aware of the manufacturer’s Field Safety Notice (FSN) and encourage patients to apply the key frames.