Company: Insulet Corporation
Date of Enforcement Report: 4/1/2020
Class II
PRODUCT
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).
- Recall Number: Z-1553-2020
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.
RECALLING FIRM/MANUFACTURER
Insulet Corporation on 2/13/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
32756 (US), 1420 (International)
DISTRIBUTION
US Nationwide and International