People with diabetes using insulin pens from a number of faulty batches manufactured by Owen Mumford are at risk of hyperglycaemia, according to an alert issued by the UK medicines regulator.
The fault can cause the dose selector to revert to zero, leading to an under dose of insulin or no insulin at all.
“It is vital that people check if they have these affected pens and should obtain an alternative device before stopping using them,” says Neil McGuire, clinical director of devices for the Medicines and Healthcare products Regulatory Agency (MHRA). “Patients who experience unexpectedly raised blood glucose on self-testing or symptoms of hyperglycaemia, regardless of which insulin delivery device they are using, should contact a healthcare professional immediately if it does not respond to their usual rescue treatment.”
The MHRA says the failure rate of the devices is 42% and people should seek a replacement as soon as possible from the manufacturer Owen Mumford or their pharmacist.
A medical device alert lists the affected batches of Autopen Classic 1 unit pens, Autopen Classic 2 unit pens, Autopen 24 1 unit pens and Autopen 24 unit 2 pens.