I was diagnosed with type 1 diabetes at the age of 7. I use a medical device called an insulin pump to manage my diabetes.
For diabetics, insulin pumps are critical for maintaining one’s health. These revolutionary devices are time-saving and life-saving solutions, helping diabetics electronically control their blood sugar levels without the constant need for insulin injections.
While insulin pumps can dramatically enhance the quality of life of a diabetic, any possible malfunction is hugely problematic.
I use an insulin pump manufactured by Medtronic. One day I suddenly fell extremely ill while shopping. I sat down, pulled out my trusty blood testing kit and found my blood sugar to be over 400 (normal is between 80-120). There was something wrong with my Medtronic insulin pump. As it turned out, I received a recalled batch of Medtronic insulin pump supplies. I immediately broke out my emergency insulin and managed the issue. But what if I didn’t have my emergency supplies? What if it happened when I was sleeping?
Needless-to-say the transcript of my call to Medtronic after that event is likely hanging somewhere as the world’s most hostile consumer complaint. All joking aside, what concerned me the most was that the issue that caused my high blood sugar could have been prevented with proper quality control. Now we have another insulin pump screw up by Animas, a division of Johnson & Johnson. But this time, unlike Medtronic, Johnson & Johnson allegedly continued to sell the product after it was notified it was defective.
The FDA recently notified Johnson & Johnson about the defects and quality control issues found in insulin pumps sold by Animas. Earlier in the year, defects in the pumps’ keypads were brought to light. These flaws, according to the FDA, could have a negative impact on the health of users, which could be potentially lethal. While the inquiry prompted Johnson & Johnson to change suppliers for future equipment needs, the company continued selling the defective pumps despite evidence that such products could compromise consumer health. This prompted the FDA’s notice, which was sent out to the company in late 2011.
Although Johnson & Johnson released a statement that it intends to cooperate with the FDA, the notice does bring into question the quality control measures in place at the company. If the company fails to make an adequate explanation or does not make necessary quality control improvements, the company may also be cut off from future government contracts. This latest run in with the FDA is not the company’s only trouble on this front. In fact, the FDA’s letter also mentioned a string of quality control issues over the last few years, involving investigations of J&J products ranging from over the counter medications and artificial hips.
The FDA gave Johnson & Johnson 15 days to respond appropriately to the concerns listed in the formal complaint. While the letter was sent late last year, the specifics were only made public this week, alerting all consumers to the growing concerns over the company’s products and processes.
The FDA’s comments were directed less toward the initial defect in the pumps and were more concerned with the company’s failure to remove all such pumps from stores. Without knowing all the details, this sounds like yet another example of putting profits over people.
For more information about this issue, please visit
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm285656.htm.