A recall notice for CareLink (CL) Software and CL System using CareLink Reports supplied by Medtronic Australasia Pty Ltd as following an update to CareLink software on 29 August, 2020, consumers who generated a report from CareLink Personal or CareLink system software may have been presented with an inaccurate carbohydrate ratio setting on their CareLink report.
Medtronic Australasia Pty Ltd - CareLink (CL) Software and CL System using CareLink Reports
PRA No.
2020/18708
Date published
3 Dec 2020
Product description
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)
What are the defects?
Following an update to CareLink software on 29 August, 2020, consumers who generated a report from CareLink Personal or CareLink system software may have been presented with an inaccurate carbohydrate ratio setting on their CareLink report.
This only occurred under the following circumstances:
- The carbohydrate unit of measurement in CareLink software is set to grams, but the insulin pump is set to exchanges.
- The carbohydrate unit of measurement in CareLink software is set to exchanges, but the insulin pump is set to grams.
What are the hazards?
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.
What should consumers do?
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.
Supplier
Where the product was sold
Nationally
International
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.
Product category
