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CareLink Personal Software and CareLink System

Official notice

20 Dec 2020

Last checked

20 Dec 2020

High riskACCC

An official ACCC notice concerns CareLink Personal Software and CareLink System. If incorrect information is used to make treatment decisions, this could lead to either over or under delivery of insulin. This could cause low blood glucose (hypoglycemia, loss of consciousness, seizure, death), and/or high blood glucose (hyperglycemia) which can lead to serious health complications. Published 2020-12-20.

What to do now

Medtronic will contact affected users in writing. On November 12 2020, a new version of the CareLink uploader was released. This uploader completely resolves the issue but must be installed on each computer that consumers use to upload devices to the CareLink system. Users are advised to install the new CareLink uploader version 3.1.6.000. Only the latest version of the CareLink Uploader is available from the CareLink website. Consumers who may have adjusted their insulin settings based on an impacted CareLink report should determine if corrections are needed. If transferring settings from one insulin pump to another before the new uploader has been installed, refer to the device settings in the old insulin pump only because the settings on an impacted CareLink report may be missing or incomplete until the new uploader has been installed. For further information, please contact Medtronic Customer Service by phone on 1800 777 808.

Recall number

0a367e14-e0a8-408a-8856-cb8cd9b74f0a

Official notice

2020-12-20

The hazard

If incorrect information is used to make treatment decisions, this could lead to either over or under delivery of insulin. This could cause low blood glucose (hypoglycemia, loss of consciousness, seizure, death), and/or high blood glucose (hyperglycemia) which can lead to serious health complications.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Artg Numbers

303062

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Affected products

Product 1

CareLink Personal Software and CareLink System CareLink Personal v14.1b (MMT-7333) using CareLink uploader (ACC-7350) CareLink system v3.1b (MMT-7350) using CareLink uploader (ACC-7350) ARTG 303062 (Medtronic Australasia Pty Ltd - Information system)

Risk / hazard

If incorrect information is used to make treatment decisions, this could lead to either over or under delivery of insulin. This could cause low blood glucose (hypoglycemia, loss of consciousness, seizure, death), and/or high blood glucose (hyperglycemia) which can lead to serious health complications.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

AU · Australia

Affected area 1

AU · Australia

Source & status

Source

Tier

beta

Category

ELECTRONICS

Classification

Pharmacy and medical products, Smart and interconnected devices

App estimate

high

Recall details

Recall number

0a367e14-e0a8-408a-8856-cb8cd9b74f0a

Classification

Pharmacy and medical products, Smart and interconnected devices

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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