FDA-Device2024-01-10Class I
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.
Insulet Corporation
Hazard
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.
Sold states
Worldwide distribution - US Nationwide and the countries of Germany and UK.
Affected count
27000 users
Manufactured in
50 & 100 Nagog Park, N/A, Acton, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0591-2024Don't want to check this manually?
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