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Animas Receives Warning Letter From the FDA

Animas Corporation, a division of Johnson & Johnson that manufactures insulin pumps, has been reprimanded by the FDA for not reporting serious problems resulting from use of its equipment. The parent company was warned that it could face fines and more for selling faulty insulin pumps and failing to disclose serious injuries to diabetic patients who used the OneTouch Ping and 2020 insulin pumps. According to reports, J&J continued to sell the pumps even after the company knew that some had failed.

Furthermore, the company did not submit a plan of correction to promptly report cases in which the devices might have caused or contributed to death or serious injury. Some patients who used the faulty pumps were hospitalized with dangerously high blood sugar, respiratory failure, and coma, as well as a diabetic ketoacidosis, a potentially fatal condition.

In some of the Animas pumps, the keypads that control how much insulin is automatically injected deteriorated prematurely. According to an Animas spokesperson, the company did not report three such incidents to the FDA within 30 days because in each case, the patient involved did not use the pump according to directions. In one case, the patient ignored an alarm signaling that the cap had come off the insulin cartridge inside the device, preventing insulin from being pumped into the body.

However, while Animas was working to line up a new keypad supplier, it continued to sell the old pumps. The FDA says that companies must continuously evaluate a product’s safety over its lifespan and report irregularities.

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