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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00267-1
Product Name/Description	Medtronic Paradigm Insulin Pump Model Numbers: MMT-511, MMT-515, MMT-554, MMT-715, MMT-754, MMT-512, MMT-522, MMT-712, MMT-722 ARTG Number: 95763
Recall Action Level	Consumer
Recall Action Classification	Class I
Recall Action Commencement Date	27/03/2013
Responsible Entity	Medtronic Australasia Pty Ltd
Reason/Issue	Issue 1: Loose Drive Support Cap – If the loose drive support cap is pressed on, it could result in the unintended delivery of additional insulin. Issue 2: Sensor Graph Timeout (only affects Paradigm VEO (MMT-554 and MMT-754)) – This issue could prevent the auto-resume of basal delivery 2-hours after a Low Glucose Suspend event, which can result in elevated blood glucose values. Issue 3: Water Damage– This issue may result in a pump alarm or cause the buttons to stop working.
Recall Action	Recall for Product Correction
Recall Action Instructions	Issue 1: Medtronic is asking consumers to regularly examine the pump especially after a shock or drop on a hard surface. If the drive support cap is sticking out, customers are asked to not press on this portion of the pump and to discontinue the use of the pump. Customers will need to manage their diabetes as per the back-up plan provided to them by their healthcare professional. Also, contact Medtronic 24 hour Helpline on 1800 777 808 (option 1). Issue 2: Medtronic is providing work around instructions to prevent this issue from occurring. Issue 3: Medtronic is asking customers to follow the user guide to prevent this issue from occurring.
Contact Information	1800 777 808 (Option 1) - Medtronic 24 hour Helpline