The U.S. distributor of a wearable insulin pump has received a warning from regulators for failing to promptly report that its devices may have contributed to serious injuries in some diabetics. The Food and Drug Administration wrote to DANA Diabecare USA last month, saying its procedures for reporting adverse events associated with the DANA Diabecare II pump were inadequate. DANA Diabecare Chief Executive Officer Susanne Jernigan said the New Orleans-based company had adjusted its reporting procedures to address the FDA’s concerns but disputed any serious injuries were linked to the insulin pump.
