FDA-Device2016-10-05Class II

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.

Medtronic Inc.
Hazard

Medtronic MiniMed is recalling the CareLink iPro Therapy Management Software due to a time stamp error.

Sold states
Nationwide Distribution to TN, MN, and WA
Affected count
33 units
Manufactured in
18000 Devonshire Street, N/A, Northridge, CA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2898-2016

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