MalfunctionLZG
DANA DIABECARE II
Received Aug 31, 2006 · Event occurred Jan 24, 2004
Report 9616814-2006-00046 · MDR key 2677286
Device
Generic name
Insulin Pump
Manufacturer
Sooil Development Co. Ltd.Model number
IICatalog number
NA
Lot number
NA
Product problems
- Mechanical Jam
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
PT REPORTED THAT ON/OFF BUTTON ON INSULIN PUMP WAS STUCK IN OFF POSITION. THIS IS A FIRST GENERATION INSULIN PUMP. THIS REQUIRED NO PHYSICIAN OR HOSPITAL INTERVENTION. INSULIN INJECTIONS WERE ADMINISTERED AT HOME.
Remedial action
- Replace