One Touch Ping Insulin Pump Problems Not Properly Reported by J&J

Federal regulators are accusing a subsidiary of Johnson & Johnson of failing to warn consumers about known problems with One Touch Ping insulin pumps, which were not properly reported or addressed. 

The FDA sent a warning letter to Animas Corporation late last month, indicating that the company failed to report within 30 days three serious injuries that were possibly caused by defective Animas insulin pumps.

The patients suffered high blood sugar, diabetic ketoacidosis, respiratory problems and coma due to a lack of insulin believed to be caused by problems with the pumps.

Companies are required to report problems with devices they manufacture that could cause serious injury or death within 30 days. Two of the incidents were not reported by Animas within that time frame and one was never reported at all.

The company had 15 days from receiving the letter on December 27 to respond to the allegations that it failed to properly report the incidents.

The One Touch Ping insulin pump problems appears to be related to the keypads of the device. The incidents may have been caused by either defective keypads that had deteriorated, or patient confusion and error, which still points to a problem with the pumps, because their design should prevent such errors. However, the FDA does not appear to seek an insulin pump recall at this time.

It appears, according to the FDA’s investigation, that the company realized there was a problem with the keypad, but continued to sell it while shopping for a new keypad manufacturer. Only after it found a replacement for the defective keypads did it alert consumers and the FDA that there was a problem.

Company officials have suggested that they did not see the keypad issues as a threat to patient safety.

Although the company has already responded to some of the FDA’s concerns, FDA investigators are trying to find out why Animus continued to manufacture insulin pumps that had known failures. Animas and Johnson & Johnson have failed to answer that question to the FDA’s satisfaction.

The FDA has warned the company that failure to take action to correct the violations promptly could result in seizure of products, injunctions and fines.