MalfunctionLZG
DANA DIABECARE II
Received Aug 31, 2006 · Event occurred Dec 22, 2005
Report 9616814-2006-00038 · MDR key 2677300
Device
Generic name
Insulin Pump
Manufacturer
Sooil Development Co. Ltd.Model number
IICatalog number
NA
Lot number
NA
Product problems
- Battery failure
- Image Display Error/Artifact
Patient
Not reported
- Blood glucose, high
Narrative
Description of Event or Problem
PT STATES THAT DISPLAY SCREEN OF THE PUMP IS FLASHING AND ALSO THAT THE BATTERY REQUIRED REPLACING TWO TIMES IN ONE MONTH. THIS REQUIRED NO PHYSICIAN OR HOSPITAL INTERVENTION. INSULIN INJECTIONS WERE ADMINISTERED AT HOME.
Remedial action
- Replace