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UK Health Regulators Warn about Medtronic Paradigm Ambulatory Insulin Infusion Pumps

Jun 2, 2014

On Thursday, the Medicines and Healthcare products Regulatory Agency (MHRA) issued a Medical Device Alert for Paradigm ambulatory insulin infusion pumps manufactured by Medtronic. The pumps may create a “risk of hypoglycemia due to incorrect selection and delivery of bolus amount”. The affected models include: MMT- 511, 512, 712, 712E, 515, 715, 522, 522K, 722, 722K, 523, 523K, 723, 723K, 554, and 754. Users have reported accidentally programming the pump to deliver the maximum bolus amount.

The devices administer insulin subcutaneously to treat diabetes. They are used as an alternative to insulin injections and insulin pens.

According to the MHRA website, the pumps may administer incorrect amounts of insulin, which may lead to hypoglycemia or severe hyperglycemia. In all models, the problem is mainly caused by loose drive support cap and water damage. In the Paradigm VEO MMT-554 and MMT-754 models, the problem can be caused by a programming issue related to the sensor graph timeout.

A loose drive support cap was related to one report of a serious injury, Medtronic said. Impact damage may separate the cap from the pump case. If a user tries to press the cap back, it may unintentionally deliver insulin.

All affected pumps are to be identified the alert states. The MHRA advises that a copy of Medtronic’s Field Safety Notice (FSN) dated March 2014 be issued to all staff and patients and follows several recommendations. When users go to the ‘Main Menu’ to program insulin doses, they should be aware that scrolling down allows the displayed dose to go from 0.0 units to the maximum programmed dose. Before starting delivery, the insulin dose flashing on the display screen should always be confirmed as correct. Users should also ensure that the ‘Max Bolus’ and ‘Max Basal’ are programmed for an individual patient’s needs.

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