inforMED
InjuryLZG

DANA DIABECARE II

Received Mar 21, 2007 · Event occurred Dec 11, 2006

Report 3005331755-2006-00088 · MDR key 834489

Device

Generic name

Insulin Pump

Manufacturer

Sooil Development

Model number

II

Catalog number

NA

Lot number

NA

Product problems

  • Image Display Error/Artifact
  • Improper or Incorrect Procedure or Method
  • Device Displays Incorrect Message

Patient

NA

  • Treatment with medication(s)

Narrative

Description of Event or Problem

PATIENT STATES THE PUMP HAS BEEN GIVING RANDOM ERROR MESSAGES FOR A FEW WEEKS AND THE PUMP RANDOMLY CHANGES SCREENS AND THE DISPLAY APPEARS TO DISSOLVE. THIS REQUIRED NO PHYSICIAN OR HOSP INTERVENTION. INSULIN INJECTIONS WERE ADMINISTERED AT HOME.