U.S. FDA Warns Insulin Pump Distributor<br>Issue 220 Item 1

Previous | Next

This article originally posted 10 August, 2004 and appeared in Issue 220

The U.S. distributor of a portable 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.

"Your firm received complaints regarding these pumps, which represent events that should have been reported as serious injuries," the FDA said in its letter dated July 23 and posted on its Web site on Tuesday.

In particular, evaluation of events at weekly staff meetings, to determine if they are reportable, may not provide timely and effective notification, the FDA said.

New Orleans-based DANA Diabecare had no immediate comment on the FDA letter, which warned that failure to promptly correct the matters raised could result in regulatory action that could involve seizure, injunction and money penalties.
The DANA Diabecare II insulin infusion pump is made by Sooil Development Co. Ltd of Seoul, South Korea.
====================================================

FACT: Blood pressure monitoring by patients at home is associated with better blood pressure values and improved control of hypertension than usual blood pressure monitoring in the healthcare system.
BMJ June 11, 2004