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.
Check against the official notice below — it lists the full affected range.
Insulet Corporation has recalled 1,773 units of the Omnipod DASH Insulin Management System (mmol/L configuration) distributed to Italy, the Netherlands, and the UK. After approximately two months of use, the personal diabetes manager (PDM) device's data processing can slow down, causing the Bolus Calculator to fail to accurately subtract the correct amount of insulin on board (IOB) before calculating a suggested bolus amount.
The affected devices have UDI PT000011 10385082000146 and lot numbers L000200, L000201, L000203, L000209, and L000210. The recall notice does not specify a remedy or corrective action for consumers to take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: The products were distributed to the following foreign countries: Italy, Netherlands, UK. Quantity: 1773 Lot/code info: UDI: PT000011 10385082000146; Lot Numbers: L000200, L000201, L000203, L000209, L000210
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.