Recall Z-1553-2020 ยท LZG Pump, Infusion, Insulin
Insulet Corporation
Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D001-MG-USA1 EU: PT-000010 - M/D: INT1-D001-MG PT-000011 M/D: INT1-D001-MM UDI 10385082000009 The Omnipod DASH Personal Diabetes Manager (PDM) is a mobile, handheld Android device that is intended to communicate with the Omnipod DASH Pod (pump).
| Date | Feb 13, 2020 |
| Status | Terminated |
| Reason | In certain scenarios, the Omnipod DASH PDM may suggest an inaccurate bolus amount based on a blood glucose value that is more than 10 minutes old when the user does not exit the bolus calculator as designed or when a system alarm interrupts a bolus calculation. If the user delivers the bolus, this may lead to hypoglycemia or hyperglycemia. |
| Root cause | Software design |
| Action | On February 14, 2020, the firm notified all affected customers of the recall via Urgent Medical Device Correction letters through email and post; the customer communication was also posted on the firm's website. Customers were informed of the product issue and provided with the following precautions: 1. Always enter a current BG into the Bolus Calculator before giving a bolus. This will replace the old BG value and ensure an accurate dose is calculated based on the current BG. 2. Total Bolus should always be the sum of the Meal Bolus and Correction Bolus. The firm will be making a software |
| Quantity | 32756 (US), 1420 (International) |
| Distribution | US Nationwide distribution. Foreign distribution to Italy, Netherlands, and United Kingdom. |
| 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 |