inforMED
InjuryLZG

DANA DIABECARE II

Received Oct 25, 2006 · Event occurred Sep 17, 2006

Report 3005331755-2006-00080 · MDR key 3172740

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

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

PT STATES THAT THE PUMP WILL NOT PRIME OR BOLUS. THE DISPLAY SCREEN SEEMS TO FADE ALSO. THIS REQUIRED NO PHYSICIAN OR HOSPITAL INTERVENTION. INSULIN INJECTIONS WERE ADMINISTERED AT HOME. REFERENCE MFR 9616814-2006-00080.