FDA: J&J Could Face Penalties for Not Reporting Insulin Pump Failure

The FDA has warned Johnson and Johnson (J&J) that it could face penalties for not reporting incidents in which the company's insulin pumps have failed.

According to a letter from the FDA, J&J should have reported incidents where device failure could have led to injury, including diabetic ketoacidosis. They also noted that J&J failed to develop a system for making adequate medical device reports. The letter was drafted following a site visit in 2011.

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