The FDA has issued a class two device recall for Senseonics’ Eversense continuous glucose monitoring system. This posting follows a September notice from the company that alerted providers and distributors in the US that the sensors of certain devices may stop working prematurely.
Senseonics identified a small number of Eversense Sensors that have prematurely stopped functioning due to inadequate hydration of the sensor’s glucose-sensing membrane,” the company wrote in its alert notice.
“Our investigation found the presence of residual sodium chloride solution used during the manufacturing process from one specific manufacturer. In such cases, the Eversense CGM System stopped displaying glucose information to the user and ended sensor life earlier than expected (within first 3 weeks following insertion).”
MobiHealthNews has reached out to Senseonics for additional comment on the recall’s progress, and will update the story with the company’s response.
WHAT’S THE IMPACT
The recall is limited to 844 sensors shipped from multiple lots between March 19 and August 19. It does not affect systems marketed outside of the US, or the company’s Eversense Smart Transmitter, Eversense Insertion Kit or Eversense App.
Senseonics said that as of September 4, it was aware of 24 sensors that had stopped functioning prematurely, which it said represents 1.4% of sensors that were inserted into patients during the affected time frame.
The FDA and Senseonics advised providers to return these affected products and not insert them into patients. However, since the reading accuracy of these devices is not being affected by the manufacturing error, the FDA and Senseonics said that sensors already inserted into patients should not be removed until the glucose readings stop, which is indicated by an alert within the app.
Senseonics said in September that it was not aware of any injuries related to the faulty sensors. Still, removal of the sensors is painful and inconvenient for patients, and comes with a very small chance of infection — a rate of 0.42% according to the company’s post-market analysis.
THE LARGER TREND
The manufacturing error and recall is a bump on the road for Senseonics, which has been full steam ahead since its implantable CGM system received a green light from the FDA in June 2018. Since then the company has launched its product within the US, kicked off programs to provide patients with the system at a lower price and became the third company to secure a non-adjunctive indication from the regulator (which allows the system to be used for insulin dosing in lieu of a fingerstick glucometer). The company is also aiming to go live with a new product and app in Q4 2019 making use of the indication.
ON THE RECORD
“Senseonics has implemented changes in the manufacturing process to address this issue and ensure appropriate removal of sodium chloride,” the company wrote in its notice. “Senseonics is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause.”