Device product
DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data.
Z-0492-2013
Product summary
- Event
- Event 63312
- Status
- Terminated
- Classification
- Class II
- Quantity
- 479 units
- Official record key
device-enforcement:Z-0492-2013
Official wording
Reason: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Code information: Device-associated diagnostic software
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Device software or design
software issue