inforMED
InjuryLZG

DANA DIABECARE II

Received Mar 21, 2007 · Event occurred Dec 7, 2006

Report 3005331755-2006-00086 · MDR key 834468

Device

Generic name

Insulin Pump

Manufacturer

Sooil Development

Model number

II

Catalog number

NA

Lot number

NA

Product problems

  • False Reading From Device Non-Compliance
  • Failure to Pump

Patient

NA

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

Narrative

Description of Event or Problem

PATIENT STATES THE COUNTER OF THE PUMP WAS NOT WORKING. SHE SAID THE PUMP REGISTERED 223 UNITS OF INSULIN REMAINING YET THE CARTRIDGE WAS EMPTY. THIS REQUIRED NO PHYSICIAN OR HOSPITAL INTERVENTION. INSULIN INJECTIONS WERE ADMINISTERED AT HOME.