MalfunctionLZG
DANA DIABECARE II
Received Aug 31, 2006 · Event occurred Apr 10, 2006
Report 9616814-2006-00055 · MDR key 2677289
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
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
PATIENT CLAIMS TO HAVE DROPPED PUMP AND IT FELL ON THE BATHROOM SINK AND CAUSED A CRACK WHICH RESULTED IN THE BOTTOM HALF OF THE PUMP CASING TO BECOME DISLODGED FROM THE PUMP. PATIENT USED TAPE TO HOLD PUMP TOGETHER. THIS REQUIRED NO PHYSICIAN OR HOSPITAL INTERVENTION. INSULIN INJECTIONS WERE ADMINISTERED AT HOME.
Remedial action
- Replace