Starting from 1 January 2022, safety alerts related to medical devices not listed under MDACS that have potential serious health risk/ public health risk to local population are listed below.
The United States Food and Drug Administration (FDA) has posted a medical device safety alert concerning Insulet Coporation 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).
According to the FDA, 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.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=93511
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 6 Jan 2024