inforMED

DANA DIABECARE II

Received Oct 25, 2006 · Event occurred Sep 8, 2006

Report 3005331755-2006-00091 · MDR key 3167976

Device

Generic name

Insulin Pump

Manufacturer

Sooil Development

Model number

II

Catalog number

NA

Lot number

NA

Product problems

  • Battery failure

Patient

NA

  • Blood glucose, high

Narrative

Description of Event or Problem

PT STATES THAT THE BATTERY IN THE PUMP IS HAVING TO BE REPLACED EVERY 10 DAYS. THIS REQUIRED NO PHYSICAL OR HOSPITAL INTERVENTION. INSULIN INJECTIONS WERE ADMINISTERED AT HOME.