Urgent Device Corrections

URGENT MEDICAL DEVICE CORRECTIONS

Omnipod 5

Insulet is conducting a voluntary Medical Device Correction for specific lots of Omnipod® 5 Pods due to a manufacturing issue we identified through our ongoing product monitoring. This issue is isolated to identified lots distributed in the United States only. Pods not included in these lots, as well as all other Omnipod® 5 Pods and Omnipod® products remain safe to use. For more information and to check the lot numbers on your pods, please visit the following link:

https://www.omnipod.com/mdc-3-26

True Metrix Blood Glucose Monitoring Systems

The correction involves the E-5 Error Code in the “Messages” section of the Owner’s Booklets/System Instructions for Use. The system displays an E-5 error code for a very high blood glucose event (> 600 mg/dL) or when there is a test strip error.  As currently written, the instructions could potentially lead to a delay in treatment if the user does not seek medical attention immediately when they receive an E-5 error code and are experiencing symptoms of high glucose. A delay in treatment may result in serious adverse health consequences or death, especially for users with very high blood glucose levels.

Trividia is updating the E-5 Error Code actions to emphasize that users must seek medical attention immediately if they receive an E-5 error code and are experiencing symptoms of high glucose. Trividia Health will notify users of additional mitigation strategies as needed.

For more information, please visit: https://www.trividiahealth.com/e-5productnotice/

FreeStyle Libre 3 and Libre 3 Plus Sensors

Internal testing determined that some sensors may provide incorrect low glucose readings. How does this impact you?

  • Medical device correction impacts a subset of FreeStyle Libre 3 and Libre 3 Plus sensors
  • Consumers can visit www.FreeStyleCheck.com to see if their sensors are affected and to get a replacement at no charge
  • Abbott has identified and resolved the manufacturing issue related to this device action
  • No other Libre family sensors, readers or apps are impacted