MalfunctionLZG
DANA DIABECARE II
Received Aug 31, 2006 · Event occurred Dec 14, 2005
Report 9616814-2006-00037 · MDR key 2677301
Device
Generic name
Insulin Pump
Manufacturer
Sooil Development Co. Ltd.Model number
IICatalog number
NA
Lot number
NA
Product problems
- High Test Results
Patient
Not reported
- Blood glucose, high
Narrative
Description of Event or Problem
PT STATES THAT BLOOD GLUCOSE LEVEL ELEVATED AFTER LAST 5.0 UNIT OF INSULIN WAS ADMINISTERED. THIS REQUIRED NO PHYSICIAN OR HOSPITAL INTERVENTION. INSULIN INJECTIONS WERE ADMINISTERED AT HOME.
Remedial action
- Replace