CareLink (CL) Software and CL System using CareLink Reports
Published 3 December 2020
Product
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)
Why it was recalled
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: 1. The carbohydrate unit of measurement in CareLink software is set to grams, but the insulin pump is set to exchanges. 2. The carbohydrate unit of measurement in CareLink software is set to exchanges, but the insulin pump is set to grams.
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.
Source: Product Safety Australia. RecallMatch AU provides a screening summary and is independent of the ACCC.