MalfunctionLZG
DANA DIABECARE II
Received Aug 31, 2006 · Event occurred Apr 24, 2006
Report 9616814-2006-00059 · MDR key 2677246
Device
Generic name
Insulin Pump
Manufacturer
Sooil Development Co., Ltd.Model number
IICatalog number
NA
Lot number
NA
Product problems
- Improper or Incorrect Procedure or Method
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
PATIENT STATES THAT THE UP AND DOWN BUTTONS OF THE PUMP ARE REVERSING AND THAT THE PUMP RESETS ALL THE TIME AND BASAL INFO DAILY. THIS REQUIRED NO PHYSICIAN OR HOSPITAL INTERVENTION. INSULIN INJECTIONS WERE DONE AT HOME.
Remedial action
- Replace