PRA number
2020/18741
Published date
Product description
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)
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)
Reasons the product is recalled
A software defect in CareLink Uploader Build 3.1.2 to 3.1.5, may lead to data uploads to the CareLink Personal and CareLink system software being affected by RF interference from surrounding equipment and result in the following:
1. The report may be missing all basal rates that are programmed in the device, and the 24-hour basal total will appear to be incorrectly blank.
2. The report may only display certain programmed basal rates and some other basal rates that are programmed in the device may be missing from the report. This will result in a miscalculation on the Device Settings report of the 24 -hour basal total.
Actual delivered insulin calculations in all reports are not impacted, including total daily dose and total basal delivery.
1. The report may be missing all basal rates that are programmed in the device, and the 24-hour basal total will appear to be incorrectly blank.
2. The report may only display certain programmed basal rates and some other basal rates that are programmed in the device may be missing from the report. This will result in a miscalculation on the Device Settings report of the 24 -hour basal total.
Actual delivered insulin calculations in all reports are not impacted, including total daily dose and total basal delivery.
The hazards to consumers
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.
What consumers should do
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.
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.
Supplier
Where the product was sold
Nationally
International
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.