Medtronic CareLink iPro Therapy Management Software, MMT-7340 The CareLink iPro Therapy Management Software (model, MMT-7340) is intended to be used by a healthcare professional (HCP) with the iPro2 CGM System and provides upload support for the iPro2 Recorder. The CareLink iPro software is used to upload glucose sensor data stored on a recording device, capture BG meter readings through manual entry or wired-upload, retrospectively calibrate sensor data, and provide retrospective reports of continuous glucose information. The reports generated by the CareLink iPro software are intended for use by healthcare professionals to assist with diabetes clinical assessment, patient education, and therapy optimization.
This recall has been terminated (originally issued October 10, 2017).
- Company
- Medtronic Inc.
- Recall Initiated
- October 10, 2017
- Terminated
- March 26, 2021
- Recall Number
- Z-0670-2018
- Quantity
- 488 uploads
- Firm Location
- Northridge, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Due to a time conversion error, data uploaded from the iPro(TM)2 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 September 23, 2017 and September 27, 2017 that used the new CareLink iPro Uploader feature.
Distribution
Worldwide Distribution - US Distribution
Lot / Code Info
Version 1.12
Root Cause
Software Manufacturing/Software Deployment
Action Taken
A communication is being sent to all healthcare professionals who had uploaded reports using the universal uploader feature between September 23, 2017 to September 27, 2017. The method is by mail and by email, with a response requested from the healthcare professional to confirm they have received and read the notice. For further questions please call (877) 874-7717