Alert Issued Regarding Medtronics Paradigm Ambulatory Insulin Infusion Pumps

Risk Of Hypoglycaemia Raised In Notice

04.06.2014

An alert has been issued by the Medicines and Healthcare Products Regulatory Agency (MHRA) after concerns were raised by users of Medtronic’s paradigm ambulatory insulin infusion pumps regarding the potential risk of hypoglycaemia.

According to the body, Medtronic has received reports of users accidentally programming the pump to deliver the maximum bolus amount.

MHRA has stated that any bodies responsible for the use and maintenance of such departments and patients need to identify affected pumps and also receive a Field Safety Notice which outlines recommendations  for avoiding the problem.

The models affected by the issue include MMT - 511, 512, 712, 712E, 515, 715, 522, 522K,
722, 722K, 523, 523K, 723, 723K, 554, and 754.

Expert Opinion
It is very worrying to hear reports of this issue emerging on some models of this device and it is vital that any organisation or person with access to the affected models seeks advice as soon as possible.

"Hypoglycaemia is a very serious condition which can lead to long-term health problems, so it is vital that everything possible is done to ensure that patients get the right support on this matter and do not face unnecessary risks.

"The safety of those using these devices must come first."
Kevin Timms, Solicitor