MalfunctionLZG
DANA DIABECARE II
Received Aug 31, 2006 · Event occurred Jan 30, 2006
Report 9616814-2006-00049 · MDR key 2677294
Device
Generic name
Insulin Pump
Manufacturer
Sooil Development Co. Ltd.Model number
IICatalog number
NA
Lot number
NA
Product problems
- Component(s), broken
Patient
Not reported
- Blood glucose, high
Narrative
Description of Event or Problem
PT CLAIMS, BUTTON OF PUMP BROKE OFF. THIS REQUIRED NO PHYSICIAN OR HOSPITAL INTERVENTION. INSULIN INJECTIONS WERE ADMINISTERED AT HOME.
Remedial action
- Replace