Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010 M/D: INT1D001MG - 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 is recalling the Omnipod DASH Insulin Management System (mg/dL configuration, Catalog Number PT000010) due to a data processing issue in the Personal Diabetes Manager (PDM) device. After approximately 2 months of use, the PDM's processing speed can slow down, causing the Bolus Calculator to fail to accurately subtract the correct amount of insulin on board (IOB) before suggesting a bolus dose to the user.
The recall affects 400 units with Lot Number L000202 that were distributed to Italy, the Netherlands, and the United Kingdom. The record does not specify what action affected consumers should 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: 400 Lot/code info: UDI: PT - 000010 - 10385082000139; Lot Numbers: L000202
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.