FDA warns J & J on insulin pumps
Johnson & Johnson could face penalties for not reporting incidents where insulin pumps have failed, the Food and Drug Administration has warned.
In a Dec. 27 letter to the company's Animas Corp. unit, the FDA says the company should have reported incidents where the device failure may have caused injury, including diabetic ketoacidosis. It also said Animas failed to create a system for making adequate medical device reports.
The letter, which was made public last week, followed a site visit in 2011. It warns “failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice.”
Diabetes is among the top ten leading causes of death in the U.S. Insulin pumps deliver rapid- or short-acting insulin throughout the day via a catheter rather than require a person or caregiver to do periodic injections.