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.
Recall
- Recall Number
- Z-2164-2020
- Event Number
- 85552
- FEI Number
- 3014585508
- Product Code
- LZG
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- April 2, 2020
- Terminated
- September 14, 2021
- Address
- Insulet Corporation 100 Nagog Park, Acton, MA, 01720-3440
Description
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.
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.
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 use the Bolus Calculator by entering through the Bolus Button on the Home screen. How will Insulet fix the software issue? A software update is being made to fix this issue, along with the issue described in the February 2020 notice and an updated replacement Omnipod DASH" PDM will be provided from August 2020. Once available, we will contact users directly via email or letter to arrange shipping. If you have received an email from Insulet providing you with the information covered in this letter and you have already responded, you do not need to do anything more at this time. If you have not received an email, we would ask that you go our website to confirm receipt of this letter and provide the Serial Number of your Omnipod DASH" PDM to ensure a replacement is reserved for you. If you would like additional information, our Customer Care is available 24/7 on 0800 011 6132 (+44 (0) 203 887 1709 when calling from abroad) or by email [email protected].
The products were distributed to the following foreign countries: Italy, Netherlands, UK.
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