Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 Ap
Summary
The FDA issued a Class I for Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 by Insulet Corporation. Reason: 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.
Details
Source
Device Recall
External ID
Z-0591-2024
Action Date
2024-01-10
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: UDI/Model/NDC Number: " Omnipod 5 App Software UDI: 1038508112030 " EU locked-down Controller UDI: 10385083000190 and 10385083000206
Quantity Affected: 27000 users
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.
Distribution
Worldwide distribution - US Nationwide and the countries of Germany and UK.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-30
Company
Acton, MA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 84 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Insulet Corporation has 17 FDA actions in our database, including 7 recalls and 10 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Insulet Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Insulet Corporation have FDA actions?
Insulet Corporation has 17 FDA actions in our database, including 7 recalls and 10 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0591-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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