Device product
Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1
Z-0347-2020
Product summary
- Event
- Event 82003
- Status
- Terminated
- Classification
- Class II
- Quantity
- 264
- Official record key
device-enforcement:Z-0347-2020
Official wording
Reason: There is a potential for a communication interruption following a bolus command that may result in inaccurate information presented in insulin on board (IOB), last bolus field or bolus history.
Code information: Lot Numbers L000120, L000121, L000122, L000123, L000124, L000131, L000132, L000133, L000135, L000136
Distribution pattern: US Nationwide.
Derived failure modes
-
Unknown
There is a potential for a communication interruption following a bolus command that may result in inaccurate information presented in insulin on board (IOB), last bolus field or bolus history.