Company: Medtronic MiniMed Inc.
Date of Enforcement Report 3/11/2015
Class lII:
PRODUCT
CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application designed to enhance Health Care Provider management of diabetic patients using Medtronic insulin pumps and blood glucose meters. MMT-7335 is intended for use by Health Care Providers/Physicians as a therapy management accessory to: – read and store history and settings data supported insulin pump models and supported blood glucose meters – read and report user-programmable settings on supported pump models – read device data from the CareLink Online system – write new device data to the CareLink system – generate reports from the patient records for use in managing the patient’s therapy. CareLink Clinical Medtronic CareLink MMT-7334 is a network based software system residing on a computer server platform connected to the Internet. The system is designed to upload patient data from Medtronic MiniMed insulin pumps and supported third-party blood glucose meters to the MMT-7334 central database via a client PC (Personal Computer), which connects to supported devices. The data contained in MMT-7334 is accessible to users using a standard browser, i.e. Microsoft Internet Explorer, on a PC that is connected to the Internet. The user may view and print various reports generated from the device data uploaded to MMT-7334, plus additional information provided by the user. The product does not provide any medical advice to patients or physicians. This is currently only intended to be used in Clinical Trials. Both products are CD ROMs.
Recall Number Z-1228-2015
REASON
The firm is informing customers of a software error that might result in an inaccurate display of the Temp Basal time and duration in CareLink Clinical reports with data uploaded from the MiniMed 620G or 640G insulin pump.
RECALLING FIRM/MANUFACTURER
Medtronic MiniMed Inc, Northridge, CA. 11/10/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
5 CareLink Pro 4.0 CD ROMs
DISTRIBUTION
Worldwide Distribution to Japan only. CareLink Clinical is for clinical trials only (US and International)
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