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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic CareLink iPro Therapy Management Software, MMT7340

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  Class 2 Device Recall Medtronic CareLink iPro Therapy Management Software, MMT7340 see related information
Date Initiated by Firm October 10, 2017
Create Date February 21, 2018
Recall Status1 Terminated 3 on March 26, 2021
Recall Number Z-0670-2018
Recall Event ID 78298
PMA Number P150029 
Product Classification Artificial pancreas device system, threshold suspend - Product Code OZO
Product 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.
Code Information Version 1.12
Recalling Firm/
Manufacturer		 Medtronic Inc.
18000 Devonshire St
Northridge CA 91325-1219
For Additional Information Contact Medtronic Helpline
877-874-7717
Manufacturer 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.
FDA Determined
Cause 2		 Software Manufacturing/Software Deployment
Action 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
Quantity in Commerce 488 uploads
Distribution Worldwide Distribution - US Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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