The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a medical device safety alert concerning Dana Diabecare R Insulin Pump, manufactured by SOOIL Development.
An update of Instructions for Use and software controlling minimal basal rate is required in existing/ in-use Dana Diabecare R Insulin Pumps having serial numbers beginning AJJ, AK, AL, and AM manufactured after 20 Sep 2009.
The manufacturer advises that this pump model is unsuitable for delivery of minimal basal rates below 0.04u/h.
The manufacturer advises affected users to take the following actions:-
- Users should return the affected devices to the distributors for modification. In the immediate term, users who absolutely require a minimal basal rate of less than 0.04u/h, and whose pumps are so set, should seek an alternative model capable of the rate required and discontinue use of the Dana Diabecare R model in use as soon as possible, at the same time notifying the manufacturer or the distributor.
- Users with pumps set through "Doctor Mode" to deliver 0.01u/h should reset them through the same means to deliver a minimal basal rate of not less than 0.04u/h, and notify the manufacturer or the distributor.
- Distributors will contact every pump user to deliver revised IFU and with a view to upgrading the pump software to prevent setting of basal rates below 0.04u/h. Pumps whose current software prevents use at minimal basal rate settings below 0.1 u/h (the default value) may be upgraded to provide a minimal basal rate of 0.04u/h only of the user so requires.
According to the manufacturer, the affected devices were not distributed in Hong Kong.
For details, please refer to MHRA website
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON231539
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 14 February 2013