MalfunctionLZG
DANA DIABECARE II
Received Aug 31, 2006 · Event occurred Nov 14, 2005
Report 9616814-2006-00030 · MDR key 2677305
Device
Generic name
Insulin Pump
Manufacturer
Sooil Development Co., Ltd.Model number
IICatalog number
NA
Lot number
NA
Product problems
- Image Display Error/Artifact
- Improper or Incorrect Procedure or Method
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
PT STATES THAT THE PUMP WILL NOT PROCEED BEYOND THE PUMP SCREEN. PT SPOKE WITH PHYSICIAN AND WAS INSTRUCTED TO CONVERT BACK TO INJECTIONS. INSULIN INJECTIONS WERE ADMINISTERED AT HOME.
Remedial action
- Replace