Pt hospitalized for high blood sugar. Pt feeling bad after lunch with blood glucose up to about 300. Blood glucose stayed elevated through evening and pt went to hosp. When pt evaluated her pump and cartridge set-up, she discovered that the piston rod was not correctly seated into the plunger of the cartridge. Pt switched to back-up pump, new cartridge and infusion set and blood glucose normal. User error attributed to this event.

Continuous insulin infusion therapy (ciit) requires that the pt continually assess the impact of such factors as their caloric intake, activity levels and other medical conditions and/or treatments on their blood glucose level. The therapy also requires periodic self-testing of actual blood glucose levels. The level of insulin delivery requested from the insulin infusion pump must be adjusted according to these tests and assessments. In the event of a failure of the pump or set to deliver insulin, the pt is instructed to use their back-up pump and/or replace the infusion set. If this does not resolve the problem, they must administer insulin by injection to restore their blood glucose to an acceptable level. Failure to monitor and/or adjust the insulin amount appropriately will result in erratic blood glucose levels. Extreme excursions from normal blood glucose levels can result in conditions such as diabetic ketoacidosis (dka), extreme hypoglycemia or insulin shock. Pts experiencing these conditions will require hospitalization and medical intervention to preclude serious medical conditions including death. A full eval of the pump showed that it was working properly and passed all delivery tests. The event was likely caused due to the misalignment of the piston rod by the pt. Disetronic has concluded that the device operated within specifications and did not cause or contribute to the incident.