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U.S. Department of Health and Human Services

Class 2 Device Recall Omnipod DASH Insulin Management System

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  Class 2 Device Recall Omnipod DASH Insulin Management System see related information
Date Initiated by Firm April 02, 2020
Create Date May 29, 2020
Recall Status1 Terminated 3 on September 14, 2021
Recall Number Z-2165-2020
Recall Event ID 85552
510(K)Number K192659  
Product Classification Pump, infusion, insulin - Product Code LZG
Product Omnipod DASH Insulin Management System (mmol/L
configuration), Catalog Number PT000011 M/D: INT1D001MM - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
Code Information UDI: PT000011 10385082000146; Lot Numbers: L000200, L000201, L000203, L000209, L000210
Recalling Firm/
Manufacturer		 Insulet Corporation
100 Nagog Park
Acton MA 01720-3440
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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 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 omnipod-GB@insulet.com.
Quantity in Commerce 1773
Distribution The products were distributed to the following foreign countries: Italy, Netherlands, UK.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LZG and Original Applicant = Insulet Corporation
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