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.

Reason: 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.

Code information: UDI: PT000011 10385082000146; Lot Numbers: L000200, L000201, L000203, L000209, L000210

Distribution pattern: The products were distributed to the following foreign countries: Italy, Netherlands, UK.