WASHINGTON (Reuters) - 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 (news - web sites) 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 (news - web sites)'s concerns but disputed any serious injuries
were linked to the insulin pump.
"Our device is not dangerous, it is not causing problems," Jernigan told
Reuters on Tuesday. "We have never had a death from our pump."
The FDA in its letter dated July 23 and posted on its Web site on
Tuesday, said: "Your firm received complaints regarding these pumps,
which represent events that should have been reported as serious
injuries ..."
Jernigan said the reporting of possible adverse events began immediately
under new procedures without waiting for weekly staff meetings or any
gatekeeping by senior executives.
The DANA Diabecare II insulin infusion pump is made by Sooil Development
Co. Ltd of Seoul, South Korea (news - web sites).