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).

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.

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 update to the next version of Omnipod DASH PDM which will provide a solution for this issue and is expected to be available starting March 2020. The firm will be voluntarily providing a replacement PDM to all existing Omnipod DASH users. The firm will contact users directly when replacements are ready to be shipped. Customers may visit www.omnipod.com for updated information on PDM replacement timing. In the meantime, the firm states that customers may continue using their current Omnipod DASH PDM provided you follow the above precautions. If you have any questions regarding the information provided in this Medical Device Correction, please contact 1-800-581-6359.