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 The Food and Drug Administration ordered J&J's Animas Corp. unit to promptly provide a plan to rectify its failure to report within 30 days cases where its device may have caused or contributed to death or serious injury.In a warning letter sent to Animas on Dec. 27 and posted online by FDA Tuesday, the agency wrote that inspectors found Animas, which is based in West Chester, Pa., never reported on one case of serious patient injury and delayed reporting on two others. Those patients were hospitalized with dangerously high blood sugar, respiratory failure and coma, and a life-threatening complication called diabetic ketoacidosis that's caused by lack of insulin to break down blood sugar.
Insulin pumps, which are about the size of a cell phone, automatically inject small amounts of insulin throughout the day to keep diabetics' blood sugar at a safe level. Patients program the device to inject additional insulin right before a meal or snack, according to the amount of carbohydrates about to be eaten.
At least some of the cases involve keypads on the insulin pumps, used to control how much insulin they push into the bloodstream, not working properly because of deterioration or patient confusion or error.
The warning follows a string of nearly 30 product recalls announced by Johnson & Johnson since September 2009, that included millions of bottles of nonprescription medicines for children and adults, prescription drugs for seizures and HIV, faulty hip implants and contact lenses that stung the eyes.
The letter states that the initial response from Animas to the problems detailed in the inspection report was not adequate. It gives the company, part of New Brunswick, N.J.-based J&J, 15 business days to respond.
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"We are dedicated to quickly resolving the FDA's outstanding concerns," Animas spokeswoman Caroline Pavis wrote in response to questions from The Associated Press.
She noted the FDA warning letter "did not request the removal or replacement of our products in the hands of patients, and the letter does not prohibit us from manufacturing and shipping product."
Pavis wrote that some patients' pump keypads had gradually deteriorated, requiring a replacement under warranty, and said J&J has since implemented a change in a component of the keypad to make it more durable.
The letter states that if the company doesn't promptly correct the violations, it could face seizure, injunction, and fines, and could lose contract awards from federal agencies.
In early afternoon trading, Johnson & Johnson shares were down 24 cents at $64.96.
[Associated
Press; By LINDA A. JOHNSON]
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