Reports of death with pumps prompted study of device-related adverse events

Infusion pump technology may be risky for adolescents, according to researchers who investigated pump-related adverse events reported to the FDA.

Between 1996 and 2005 1,674 reports were identified — 1,594 insulin pump-related reports and 53 patient-controlled analgesic pump-related reports.

With insulin pumps, there were 13 reported deaths related to hypoglycemic or hyperglycemic complications, seizure, coma or diabetic ketoacidosis. According to 102 (6.4%) reports, the insulin pump was a contributor to the adverse event, mainly due to compliance issues, education, sports-related activities and dropping/damaging the device. More than three-quarters (82%) of adverse event reports resulted in hospitalization.

In 2005 alone, there were 499 insulin pump-related adverse events reported to the FDA — 381 were patient injuries and 109 were device malfunctions.

With patient-controlled analgesic pumps, there were five reported deaths and 21 device malfunctions. Adolescents typically used this device to treat pain associated with illnesses such as cancer and sickle cell disease or for orthopedic conditions or pregnancy-related events. More than 50% of reports indicated that adolescents using a patient-controlled analgesic pump received an excess dose of medication. In addition, 12 cases of respiratory depression requiring medical intervention were reported.

Health care professionals should consider respiratory depression, oversedation and confusion when selecting this type of pump for adolescents, according to the researchers. They encouraged health care professionals to report adverse events with both insulin pumps and patient-controlled analgesic pumps to the FDA Medwatch Program at www.fda.gov/medwatch – by Katie Kalvaitis.

Pediatr. 2008;121:1133-1138.

There is great variability in the ability of adolescents to achieve excellent glycemic control with insulin pump use, largely based on willingness to perform the tasks needed to succeed and having the desire and intelligence to make adjustments as needed for specific situations. This study, which involved reviewing data from FDA’s Manufacturer and User Facility Device Experience Database, was prompted by reports of five deaths in youths using insulin pumps. This underscores the need to evaluate psychological and developmental readiness of teens to use the pump, as they appear to be a very vulnerable group with potential for pump misuse, potentially leading to disastrous results. The data underscore the need for prospective studies to assess characteristics that predict failure as well as success with insulin pump use.

– Janet H. Silverstein, MD

Endocrine Today Editorial Board member