Device 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.
Z-2898-2016
Product summary
- Firm
- Medtronic Inc.
- Event
- Event 74955
- Status
- Terminated
- Classification
- Class II
- Quantity
- 33 units
- Official record key
device-enforcement:Z-2898-2016
Official wording
Reason: Medtronic MiniMed is recalling the CareLink iPro Therapy Management Software due to a time stamp error.
Code information: n/a
Distribution pattern: Nationwide Distribution to TN, MN, and WA
Derived failure modes
-
Device software or design
Software due to a time stamp error