| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01306-1 |
| Product Name/Description |
CareLink iPro Therapy Management Software MMT-7340
ARTG Number: 133091 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/10/2017 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic have identified a time conversion error where data uploaded from the iPro2 recorder to the CareLink iPro software using the new CareLink iPro uploader feature may result in incorrect reports. This pertains only to reports generated between the 23rd and the 27th of September 2017 that used the new CareLink iPro uploader feature.
Specifically, when data from the iPro2 recorder was uploaded using the new CareLink iPro Uploader feature, the glucose reading timestamps inadvertently defaulted to Greenwich Mean Time (GMT) /Coordinated Universal Time (UTC). It has been determined that the difference in time zones could result in calculation and display errors on the reports. This could lead to potential differences or inaccuracies in the sensor tracings, which also affect the display of meals and activities and the resulting report.
To date, there have been no reported events to Medtronic regarding this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Medtronic has disabled the CareLink iPro Uploader feature for all users. CareLink iPro software has automatically reverted back to using the previous Java Applet function. Reports generated using the uploader feature may contain inaccurate data, and should not be used to make therapy adjustments. Medtronic advises repeating iPro2 evaluations for those studies uploaded between 24 September 2017 and 28 September 2017. Clinics do not need to uninstall the uploader feature as this has been disabled - Java Applet will upload recorder and meter data. For users with affected reports, Medtronic will be providing replacement sensors at no charge for each evaluation. There is no need to initiate a request for replacement sensors. Medtronic will notify CareLink iPro customers when the updated version of the Uploader is available.
This action has been closed out on 15/10/2018 |
| Contact Information |
1800 777 808 - Medtronic Global Helpline |