Federal regulators have warned Johnson & Johnson that it could face fines and other sanctions for selling faulty insulin pumps and delaying disclosures of serious injuries to diabetics who were using its OneTouch Ping and 2020 pumps. The FDA ordered the Animas Corp. unit of J&J to explain why it kept selling pumps known to fail and also to submit a plan to rectify a failure to promptly report cases in which its device might have caused or contributed to death or serious injury....
In the issue with the Animas insulin pumps, some pump keypads for controlling how much insulin is injected were deteriorating prematurely, leading to failures. "We decided to go with a new keypad because it's more durable," [spokesperson Caoline] Pavis said.
But while Animas was lining up the new keypad supplier, it was still selling the older ones. The FDA demanded documents about the company's decision to do that.