MHRA Medical Device Alerts

The medical devices regulator has issued a number of alerts on insulin pumps in the last few years:

  • On 16th December 2009 the MHRA issued a medical device alert related to the Minimed Paradigm Veo Insulin Pump manufactured by Medtronic. It came to light that two functions on this pump did not work correctly – the wireless meter reading and the missed bolus reminder. The blood glucose reading should disappear from the pump 12 minutes after it has been transmitted. Currently this is being displayed for longer. Users can specify a time period, around meal times, when the pump will remind them to give a bolus dose of insulin due to the software error this reminder occurs even after delivery.
  • On 17th May 2013 the MHRA issued a medical device alert in relation to the Paradigm Ambulatory Insulin Infusion Pumps manufactured by Medtronic. The problem is a risk of compromised insulin therapy, which may lead to severe hyperglycemia or severe hypoglycemia. The root causes are – a loose support cap, damage to the pump if it is immersed in water or a programming issue related to the sensor graph timeout. If the loose support cap is pressed on it can lead to unintended delivery of additional insulin.
  • On 28th August 2013 the MHRA issued a medical device alert and a recall on the Insulin Infuser Sets and Reservoirs used with Paradigm Ambulatory Insulin Pumps manufactured by Medtronic. The problem is a risk of over or under delivery of insulin which may lead to hypoglycemia or hyperglycemia. The root causes are – spillage from the insulin reservoir may block the connector vents. If the insulin is undelivered this will result in high blood sugars, which can then lead to diabetic ketoacidosis. The Medtronic, Inc. MiniMed Paradigm Insulin Pump is a small device that provides continuous doses of insulin to diabetics in order to keep their blood sugar at a normal level. After discovering potential health risks associated with the pumps, Medtronic, Inc. recalled three-million Quick-set Infusion sets that are used in conjunction with the MiniMed Paradigm Insulin Pumps. The infusion sets are disposable plastic tubes that administer the insulin to the patient. The recall was based on a manufacturing defect that may affect the air pressure in the infusion sets.

 

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