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CareLink (CL) Software and CL System using CareLink Reports

Official notice

3 Dec 2020

Last checked

3 Dec 2020

High riskACCC

An official ACCC notice concerns CareLink (CL) Software and CL System using CareLink Reports. If adjustments were made to the carbohydrate ratio based on the CareLink report, 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 2020-12-03.

What to do now

Medtronic will contact affected users in writing. Consumers who may have adjusted their carbohydrate ratio between 29 August 2020 and 30 September 2020 using incorrect data on the CareLink report, should review their carbohydrate ratio setting with a healthcare provider to determine if any corrections are needed and should discard and re-generate the Carelink report. On 30 September 2020, Medtronic released an automatic update to CareLink software which resolved the issue described. No further action is required to receive the corrected version of CareLink software. For further information, please contact Medtronic Customer Service by phone on 1800 777 808.

Recall number

7d45b9a4-dacd-4b94-87dc-390e2b57a27a

Official notice

2020-12-03

The hazard

If adjustments were made to the carbohydrate ratio based on the CareLink report, 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 (CL) software and CL System using CareLink reports Versions: v14.1a, v3.1a and v5.2b Product codes: MMT-7333, MMT-7350 and ACC-7333 ARTG 303062 (Medtronic Australasia Pty Ltd - Information system)

Risk / hazard

If adjustments were made to the carbohydrate ratio based on the CareLink report, 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

7d45b9a4-dacd-4b94-87dc-390e2b57a27a

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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