inforMED
MalfunctionLZG

DANA DIABECARE II

Received Mar 21, 2007 · Event occurred Dec 15, 2006

Report 3005331755-2006-00089 · MDR key 834483

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

Patient

NA

  • Treatment with medication(s)

Narrative

Description of Event or Problem

PATIENT STATES THE PUMP HAS A "CHECK" IN THE CORNER OF THE DISPLAY, WILL NOT ALLOW HER TO PROCEED TO DIFFERENT SCREENS. THIS REQUIRED NO PHYSICIAN OR HOSP INTERVENTION. INSULIN INJECTIONS WERE ADMINISTERED AT HOME.