CareLink (CL) Software and CL System using CareLink Reports
AustraliaCareLink (CL) Software and CL System using CareLink Reports
Reason for Recall / Hazard
TranslatedFollowing 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
TranslatedReason / 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
TranslatedCareLink (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 |
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 (CL) Software and CL System using CareLink Reports?
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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🚨 SAFETY ALERT: CareLink (CL) Software and CL System using CareLink Reports Check if your household is affected: https://therecallfile.com/recalls/carelink-cl-software-and-cl-system-using-carelink-reports/AU-7d45b9a4-dacd-4b94-87dc-390e2b57a27a
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