Recall Z-2164-2020 ยท LZG Pump, Infusion, Insulin
Insulet Corporation
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.
| Date | Apr 2, 2020 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | URGENT: Field Safety Notification letters dated 4/3/20 were sent to customers. How do users prevent this from happening? This issue is entirely preventable (see Figure 1 below) by (1) always entering the Bolus Calculator through the Bolus Button from the Home screen and (2) by never entering the Bolus Calculator through the Menu Icon. Is it safe for users to continue using the Omnipod DASH" PDM? Yes, it is safe for users to continue using the Omnipod DASH" PDM if the steps detailed above are followed to avoid incorrect bolus calculations. Users will not experience the issue if they always us |
| Quantity | 400 |
| Distribution | The products were distributed to the following foreign countries: Italy, Netherlands, UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192659 | Omnipod Insulin Management System, Omnipod DASH Insulin Management System Insulet Corporation, Oct 21, 2019 |