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.
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Learn MoreCompanies 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.
4 Comments
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BobDecember 28, 2018 at 3:00 am
I have been getting an excessive number of "pump is not primed" warnings lately. (Sometimes up to 6-8 messages per day.) It is not always easy to get to the pump through layers of clothes, and it becomes very annoying. I usually feel the vibration, even if I don't hear the warning beep. It's hard to tell how much automatic bolus I have missed during this time though, and my glucose levels have[Show More]I have been getting an excessive number of "pump is not primed" warnings lately. (Sometimes up to 6-8 messages per day.) It is not always easy to get to the pump through layers of clothes, and it becomes very annoying. I usually feel the vibration, even if I don't hear the warning beep. It's hard to tell how much automatic bolus I have missed during this time though, and my glucose levels have been all over the scale.
RonSeptember 28, 2016 at 5:02 am
My opinion is that Animus ping pumps are sub standard-I used Medtronic for years and never had a single issue that was not resolved within 24 hours. Animus customer service is generally poor. Supply orders are consistenly a lengthy problem to resupply necessary infusion sets, etc. Use of this pump is so cumbersome that user error is not "if" but "when" waiting to happen. Cannot wait for the wa[Show More]My opinion is that Animus ping pumps are sub standard-I used Medtronic for years and never had a single issue that was not resolved within 24 hours. Animus customer service is generally poor. Supply orders are consistenly a lengthy problem to resupply necessary infusion sets, etc. Use of this pump is so cumbersome that user error is not "if" but "when" waiting to happen. Cannot wait for the warrenty to expire to get back to Medtronic pump.
ChristaSeptember 22, 2016 at 11:31 pm
The no prime warnings are not innocuous and are causing highs and lows. It's time to hold Animas accountable for defective pumps.
RachelAugust 19, 2015 at 6:05 am
Animas is a nightmare. You hold for customer service for over an hour, and the person on the other line has to answer 60 questions or more before you get help. The rate of the turn over for staff is very high, yet I don't find the customer service team all that knowledgeable. Plus, if you asked why you waited all that time, they say, well, we hired new people, yet you wonder why it stll takes so l[Show More]Animas is a nightmare. You hold for customer service for over an hour, and the person on the other line has to answer 60 questions or more before you get help. The rate of the turn over for staff is very high, yet I don't find the customer service team all that knowledgeable. Plus, if you asked why you waited all that time, they say, well, we hired new people, yet you wonder why it stll takes so long. The pump is precise but the wait is atrocious. If I were buying a pump, stick with Medtronic.