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Four insulin pens manufactured by Owen Mumford have been recalled due to a dosage fault which could lead to hyperglycemia in people with diabetes.
Owen Mumford has initiated a voluntary recall of affected pens after a warning from the Medicines and Healthcare products Regulatory Agency (MHRA).
People with the Autopen Classic 1 unit pen, Autopen Classic 2 unit pen, Autopen 24 1 unit pen and Autopen 24 unit 2 pen are being warned to check if their pen is in the list of affected lots.
This fault could cause people to receive an underdose of insulin upon the dose suddenly reverting to zero, or no insulin at all.
To identify affected devices without packaging look for the following production lot codes which can be found on the lower part of the pen body.
“It is vital that people check if they have these affected pens and should obtain an alternative device before stopping using them,” said MHRA Clinical Director of Devices, Dr Neil McGuire.
“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.”
http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON491141
Owen Mumford has initiated a voluntary recall of affected pens after a warning from the Medicines and Healthcare products Regulatory Agency (MHRA).
People with the Autopen Classic 1 unit pen, Autopen Classic 2 unit pen, Autopen 24 1 unit pen and Autopen 24 unit 2 pen are being warned to check if their pen is in the list of affected lots.
This fault could cause people to receive an underdose of insulin upon the dose suddenly reverting to zero, or no insulin at all.
To identify affected devices without packaging look for the following production lot codes which can be found on the lower part of the pen body.
“It is vital that people check if they have these affected pens and should obtain an alternative device before stopping using them,” said MHRA Clinical Director of Devices, Dr Neil McGuire.
“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.”
http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON491141
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