Omnipod 5 insulin pump app bolus calculator decimal point error
The Omnipod 5 app bolus calculator may fail to record a decimal point if entered first when adjusting a dose, potentially causing insulin over-delivery. Users should verify dose values on both the calculator and confirmation screens before administering insulin.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum severity score of 4 per the rubric. No reported illnesses or injuries have been documented, but the potential for insulin over-delivery due to the calculator error represents a significant patient safety risk.
Plain-English summary
The Omnipod 5 App is a software application that controls the Omnipod 5 insulin pump. The app is being recalled due to a software error in the bolus calculator, affecting approximately 27,000 users worldwide in the US, Germany, and UK.
The bolus calculator does not record the decimal point if it is the first value entered when changing a bolus dose. This may lead to over-delivery of insulin if the user does not recognize the error on the calculator screen or the confirmation screen before starting the bolus.
Users should carefully verify the dose displayed on both the bolus calculator screen and the confirmation screen before administering insulin. If you believe you may have received an incorrect dose, contact your healthcare provider or Insulet customer support.
The recalled product
- 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…
- Manufacturer
- Insulet Corporation
- Category
- Medical Device
- Affected units
- 27,000
Distribution
Distributed nationwide across the United States.
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