Device product
OmniPod¿, Insulin Management System (OUS) Catalog Number: 14810 Product Usage: The OmnniPod¿ Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger.
Z-0394-2016
Product summary
- Event
- Event 72535
- Status
- Terminated
- Classification
- Class I
- Quantity
- 5,179.0 boxes
- Official record key
device-enforcement:Z-0394-2016
Official wording
Reason: Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.
Code information: Lot Codes: L41908, L41910, F41935
Distribution pattern: Worldwide Distribution - US Nationwide and countries of Switzerland, Germany, and Israel.
Derived failure modes
-
Unknown
Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.