CareLink (CL) Software and CL System using CareLink Reports
Reason for Recall / Hazard
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.
Product Description & Identification
Reason / 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: 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. 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 to 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.
Affected Products
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)
Additional Source Details
| Field | Value |
|---|---|
| Guid › #text | 7d45b9a4-dacd-4b94-87dc-390e2b57a27a |
| Guid › @ is Perma Link | false |
| Link | https://www.productsafety.gov.au/search-consumer-product-recalls/carelink-cl-software-and-cl-system-using-carelink-reports |
| Pub Date | Thu, 03 Dec 2020 00:00:00 +0000 |
Overview
- Risk Level["Pharmacy and medical products","Smart and interconnected devices"]
- DistributionAustralia