Important Safety Alerts

The Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom posted a medical device safety alert concerning Autopen Classic, Autopen 24, Densupen and Autopen 3ml for Teriparatide manufactured by Owen Mumford Ltd. The affected product codes are AN3800, AN3810, AN4200, AN4210, AN1281 and AN1251.

According to the manufacturer, a proportion of devices from the lot codes listed in the field safety notice have a potential mechanical fault. The fault presents itself in the following ways:

• A) A dose may be dialled-up but the dose selector will not hold that dose and instead will spin straight back to zero.
• B) The dose may be dialled-up and the dose selector will hold the dose momentarily, but will then spin back to zero.

This potential risks to patient are:

• A) the patient will not be able to use the pen, no dose can be delivered.
• B) the patient may only receive a partial dose and will not know how much insulin has been delivered.

The affected products are being recalled.

For details, please refer to the following link:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON484997

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 16 December 2014