| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01215-1 |
| Product Name/Description |
CareLink Clinical Therapy Management Software
(online diabetes management software)
Model Number: MMT-7334
ARTG Number: 133091 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/11/2014 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic has identified a software error in the CareLink Clinical Therapy Management Software that might result in an inaccurate display of Temp Basal time and duration in CareLink Clinical reports when uploading data from the MiniMed 640G (models MMT-1511 & MMT-1512) insulin pump. The overall insulin calculation and additional analysis are correct. This issue only affects the graph and the duration data point displayed on CareLink reports. This issue does not occur with uploads from other Medtronic insulin pump models.
The CareLink Clinical Therapy Management Software is only intended for use in clinical trials and should not be used to provide medical advice to patients or health care professionals. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Medtronic is informing users to not to use the Temp Basal data for clinical consideration when reviewing CareLink Clinical reports. Medtronic’s next version of CareLink Clinical software will resolve this issue and is expected to be available early next year. This action has been closed-out on 11/08/2016. |
| Contact Information |
1800 886 670 - Medtronic Australasia Pty Limited |