Dive Brief:
- Insulet issued an urgent medical device correction on Wednesday for its Omnipod 5 insulin delivery system because of an issue with the charging port and cable.
- The notice covers 24 reports of charging ports and cables “melting, deforming or discoloring due to heat generated by a poor connection.” Insulet said it has received no reports of serious injuries but warned the fault could cause minor burns or lead to fire.
- In light of the reports, the company is asking users to check their devices for signs of overheating and to disconnect the charger if they experience such issues.
Dive Insight:
Insulet’s Omnipod 5 insulin pump came to market in August and the company registered a record number of new customers for the device in the third quarter. The demand prompted the company to raise its full-year revenue forecast. Still, sales growth has come amid safety issues involving its devices — first with battery problems linked to its Omnipod DASH system and now with unrelated issues affecting Omnipod 5.
The latest problem affects the Omnipod 5 Controller charging port and cable. Android smartphones that have the Omnipod 5 app installed are unaffected, as are the Omnipod 5 Pods, the Omnipod DASH insulin management system and the Omnipod insulin management system.
In 24 cases, users of the Omnipod 5 Controller have discovered evidence of overheating. In response, the company is asking users to check their charging ports and cables, to not use third-party cables or adapters and to stop charging their devices when the battery reaches 100%. If users discover signs of overheating, they should stop charging the device and contact Insulet’s customer support team.
As well as looking for melting and other signs of overheating, Insulet asks users to check their charging ports for dust and debris. Users should use compressed air to clean ports that are filled with dust and debris, the company said.
