The MHRA has issued a Medical Device Alert (MDA/2009/083) involving the MiniMed Paradigm Veo insulin pump, manufactured by Medtronic (all serial numbers).
Two functions on this pump do not work correctly, and therefore there is a potential for inappropriate insulin administration.
Wireless meter reading: The wireless blood glucose reading should disappear from the pump display 12 minutes after it has been transmitted from the blood glucose meter. This is to ensure that old blood glucose measurements are not mistaken for the current readings. Currently a software error permits blood glucose readings to be displayed for longer than 12 minutes.
Missed bolus reminder: Users can specify a time period, around meal times, when the pump will remind them to give a bolus dose of insulin. Due to a software error this reminder occurs even after delivery of the designated bolus.
The following action is required by all medical, nursing and technical staff responsible for the distribution, use, maintenance and purchase of these devices:
• Locate and identify all affected pumps.
• Patients may continue to use the Veo pump with the two faulty functions switched off. The instructions in the manufacturer’s Field Safety Notice (dated September 2009) describe how this is done.
• Contact Medtronic who will supply a replacement Veo pump, or an alternative model, if the upgraded Veo pump is unavailable.
Please see the link below for the full alert.