CareLink Personal Software and CareLink System
Published 20 December 2020
Product
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)
Why it was 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.
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.
Source: Product Safety Australia. RecallMatch AU provides a screening summary and is independent of the ACCC.