The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom (UK) posted a field safety notice concerning the Pendiq® digital insulin pens manufactured by Diamesco Co. Ltd.
According to the safety alert, Pendiq® may malfunction while it is connected to the computer with the USB cable for recharging the battery and transferring the data. The manufacturer has modified the firmware for the Pendiq® so that the injection mode is not operated when connecting it via USB to a computer or a Pendiq® battery charger.
According to the manufacturer, the affected devices were not distributed in Hong Kong.
For details, please refer to the following MHRA website: http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/index.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 31 July 2012