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U.S. Department of Health and Human Services

Class 1 Device Recall Omnipod 5 App

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  Class 1 Device Recall Omnipod 5 App see related information
Date Initiated by Firm November 30, 2023
Date Posted January 04, 2024
Recall Status1 Open3, Classified
Recall Number Z-0591-2024
Recall Event ID 93511
510(K)Number K231826  
Product Classification Alternate controller enabled insulin infusion pump - Product Code QFG
Product Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 App Software Package (provided through Google Play), EU: PT-001323- Omnipod 5 App Software Package (provided on locked-down Controllers (PT-001194 and PT-001193). Used to control an insulin pump.
Code Information UDI/Model/NDC Number: " Omnipod 5 App Software UDI: 1038508112030 " EU locked-down Controller UDI: 10385083000190 and 10385083000206
Recalling Firm/
Manufacturer
Insulet Corporation
50 & 100 Nagog Park
Acton MA 01720-3440
For Additional Information Contact Insulet Customer Care team
800-591-3455
Manufacturer Reason
for Recall
The bolus calculator is not recording the decimal point if it is the first value entered when changing a bolus dose. This may lead to an over-delivery of insulin to the user if the user does not recognize the error on the bolus calculator screen or the confirmation screen prior to starting the bolus.
FDA Determined
Cause 2
Software design
Action An URGENT: Medical Device Correction notification letter was sent customers on 11/30/23 via email. How do you avoid giving the wrong bolus amount? 1. When changing a bolus dose to less than 1 unit, always enter a zero (0) before the decimal (e.g., enter 0.3 instead of .3) (Figure 1) 2. Always check the bolus amount shown in the Total Bolus box before tapping CONFIRM 3. Double-check the amount on the Confirm Bolus screen (Figure 2) to make sure this is the amount you want to deliver before pressing START to deliver the bolus 4. Check the amount again while the bolus is in progress on the Delivering Bolus screen (Figure 3) As stated in our User Guide, it is important to review the bolus amount before you confirm and start the bolus. The Omnipod 5 App will always deliver the amount you confirm and that is shown on the Confirm Bolus screen (Figure 2). This amount can also be checked while the bolus is in progress on the Delivering Bolus screen (Figure 3). If it s not the amount you expected, you can always CANCEL the bolus. To check how much insulin has been delivered, check the Last Bolus box on the home screen or your History Detail. When will the issue be fixed? We are working diligently to correct this issue and expect a software update as soon as possible. We will inform your patients via email and update our website when available. Once available, the update will be pushed to their device, and they will not lose settings or history because of this update. We understand this may impact your experience and are here to support you. If you have any questions regarding the information provided in this Medical Device Correction, please call 800-591-3455 to speak with a member of the Insulet Customer Care team who are available 24 hours a day, 7 days a week.
Quantity in Commerce 27000 users
Distribution Worldwide distribution - US Nationwide and the countries of Germany and 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = QFG and Original Applicant = Insulet Corporation
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