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U.S. Department of Health and Human Services

Class 2 Device Recall CareLink iPro

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  Class 2 Device Recall CareLink iPro see related information
Date Initiated by Firm August 05, 2016
Create Date September 27, 2016
Recall Status1 Terminated 3 on October 20, 2016
Recall Number Z-2898-2016
Recall Event ID 74955
Product Classification Continuous glucose monitor retrospective data analysis software - Product Code PHV
Product CareLink iPro Version 1.10, Catalog No. MMT-7340
With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retrospectively calibrates sensor data and provides reports of continuous glucose information. CareLink iPro reports show up to seven calendar days of study data. The reports are created in PDF format, so they can easily be printed or stored electronically.
Code Information n/a
Recalling Firm/
Manufacturer		 Medtronic Inc.
18000 Devonshire Street
Northridge CA 91325-1219
For Additional Information Contact
818-576-4700
Manufacturer Reason
for Recall		 Medtronic MiniMed is recalling the CareLink iPro Therapy Management Software due to a time stamp error.
FDA Determined
Cause 2		 Software design
Action Medtronic sent an Urgent Field Corrective Action letter dated August 5, 2016, to affected customers who received the CareLink iPro Therapy Management Software. The letter informed the customers that the recall affects the users of CareLink iPro software who have downloaded reports that include data that was uploaded from certain models of Roche BG meters. Customers were informed that the recall is due to time stamp error and data from certain Roche meters uploaded to CareLink iPro may resulted in incorrect reports. Customers were informed that if they manually enter Logbook data from the Roche ACCU-CHEK meters or upload data from a blood glucose meter other than the Roche meters are not affected by the recall situation. Customers with any questions regarding the recall letter are instructed to contact the Medtronic 24-Hour HelpLine at 1.800.646.4633. For questions regarding this recall call 818-576-4700.
Quantity in Commerce 33 units
Distribution Nationwide Distribution to TN, MN, and WA
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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