FDA-Device2020-06-10Class II
Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Number PT000011 M/D: INT1D001MM - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
Insulet Corporation
Hazard
After the device has been in use for about 2 months, data processing in the PDM can be slowed such that the Bolus Calculator fails to accurately subtract the correct amout of IOB before suggesting a bolus amount.
Sold states
The products were distributed to the following foreign countries: Italy, Netherlands, UK.
Affected count
1773
Manufactured in
100 Nagog Park, N/A, Acton, MA, United States
Products
Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Number PT000011 M/D: INT1D001MM - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2165-2020Don't want to check this manually?
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