CareLink Personal Software and CareLink System
AustraliaCareLink Personal Software and CareLink System
Reason for Recall / Hazard
TranslatedA 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.
Product Description & Identification
TranslatedReason / Defects: 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. Hazards: 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 to 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.
Affected Products
TranslatedCareLink 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)
Additional Source Details
| Field | Value |
|---|---|
| Guid › #text | 0a367e14-e0a8-408a-8856-cb8cd9b74f0a |
| Guid › @ is Perma Link | false |
| Link | https://www.productsafety.gov.au/search-consumer-product-recalls/carelink-personal-software-and-carelink-system |
| Pub Date | Sun, 20 Dec 2020 00:00:00 +0000 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsCheck the model number, serial number, and date stamp on the rating label on the back or underside of the product.
Immediately discontinue using the product. Unplug electrical items and keep juvenile items out of reach of children.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (Australia Products).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought CareLink Personal Software and CareLink System?
Immediately stop using the product and keep it out of reach of children. Disconnect power if electrical, and do not attempt makeshift home repairs.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (Australia Products). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Overview
- Risk Level["Pharmacy and medical products","Smart and interconnected devices"]
- DistributionAustralia
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