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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00632-1
Product Name/Description	Medtronic MiniMed 640G Insulin Pumps Model Numbers – MMT - 1511, 1512, 1711 & 1712 ARTG Number: 95763
Recall Action Level	Consumer
Recall Action Classification	Class I
Recall Action Commencement Date	20/07/2015
Responsible Entity	Medtronic Australasia Pty Ltd
Reason/Issue	Issue 1 – Users could inadvertently extend the Blood Glucose Timestamp for a given Blood Glucose value by 12 minutes leading to a potentially incorrect bolus dose calculation. Medtronic is currently not aware of any malfunctions, complaints, adverse effects, disease, illness, injuries or confirmed deaths related to this issue; and Issue 2 – The ‘Max Bolus Exceeded’ & ‘High/Low’ Blood Glucose Notification warning pop-ups for the Bolus Wizard software are not timing out which may lead to confusion. There are no reported harms due to the combination of potential user error and pop up screens not timing out.
Recall Action	Recall for Product Correction
Recall Action Instructions	Medtronic has updated the user guide to rectify this issue. For more details, please see https://www.tga.gov.au/alert/minimed-640g-insulin-pump. This action has been closed-out on 15/08/2016.
Contact Information	1800 777 808 - Medtronic HelpLine