MalfunctionLZG
DANA DIABECARE II
Received Aug 31, 2006 · Event occurred Apr 24, 2006
Report 9616814-2006-00060 · MDR key 2677274
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
- Blood glucose, high
Narrative
Description of Event or Problem
PATIENT CLAIMS CLOCK RESETS ITSELF WITH DATE AND ALSO THAT THE PUMP WILL NOT BOLUS OR PRIME.
Remedial action
- Replace