inforMED
InjuryLZG

DANA DIABECARE II

Received Mar 21, 2007 · Event occurred Dec 4, 2006

Report 3005331755-2006-00085 · MDR key 834504

Device

Generic name

Insulin Pump

Manufacturer

Sooil Development

Model number

II

Catalog number

NA

Lot number

NA

Product problems

  • Improper or Incorrect Procedure or Method
  • Device Displays Incorrect Message

Patient

NA

  • Blood glucose, high
  • Treatment with medication(s)

Narrative

Description of Event or Problem

PATIENT STATES THE PUMP DISPLAYED "CHECK" ON SCREEN. PATIENT REBOOTED THE PUMP AND FOUND THAT HIS BASAL RATES WERE RESET TO 0.2 U/HR AND THE DATE WAS SET IN 2000. THIS REQUIRED NO PHYSICIAN OR HOSP INTERVENTION. INSULIN INJECTIONS WERE ADMINISTERED AT HOME.