Korean Firm Warned for Glucose Monitor Errors
The FDA has issued a warning letter to South Korean devicemaker Philosys over adverse event reporting for its blood glucose monitor.
The company failed to notify the agency following a complaint from a customer about its Gmate VOICE blood glucose monitor. The device issued a faulty high glucose reading that led to hypoglycemia in the patient due to excess insulin.
The company claimed it submitted a medical device report to the FDA about the complaint, but the agency said it never received a report.