Johnson & Johnson Warned By FDA Over Insulin Pump Failures

By Robert Vamosi | 1/12/12 3:33 AM

In late December, the Food and Drug Administration (FDA) sent the pharmaceutical company Johnson & Johnson a letter warning of possible penalties for not reporting life-threatening vulnerabilities with its OneTouch Ping and 2020 insulin pumps. It is unclear whether the vulnerabilities are outright device failures or from interference or manipulation from outside sources.

After an inspection at Johnson & Johnson's subsidiary plant in West Chester, Pa., the FDA discovered one complaint about series patient injury and two other incidents never reported. According to the FDA one patient was hospitalized with diabetic ketoacidosis, a condition where the body does not have enough insulin. Another received high doses of insulin. And a third patient suffered serious injury, which could include coma, respiratory failure, and hypoglycemia as a result of user error.

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Senators Want Better Medical Device Safety

By Robert Vamosi | 12/19/11 3:46 AM

Three US Senators have introduced a bi-partisan Medical Device Patient Safety Act to stem medical device recalls and shore up existing FDA policy on product approval. Already one medical technology group is opposed.

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