FDA Warns Animas Corp. of Failures in an Insulin-Delivery Pump
Those of us who have or live with loved ones suffering from Type I diabetes understand the devastating effects the condition has on all aspects of life. For the diabetic, constant, 24/7 vigilance must be maintained because the pancreas — the organ that is supposed to produce insulin — does not make any insulin, requiring the diabetic to get insulin through injections or pumps.
The advent of pumps was considered a breakthrough for the diabetic because it was more efficient and less disruptive for the delivery of insulin. No longer did the diabetic have to break from what she was doing to take time to inject insulin, which for some patients might be as often as ten to fifteen time a day. With a pump, insulin is delivered throughout the day at either set or as need times and then an extra, programmed amount would be delivered with meals to break down sugars found in most foods. Absent the insulin, blood sugar levels can rise to lethal levels very quickly. Too much insulin and the diabetic can suffer from low blood sugar, which can also create health issues. That is why insulin-delivering pumps are critical in providing the right amount of insulin.
Recently, a local manufacturer of an insulin pump, Animas Corp., which is a Johnson & Johnson company, located in West Chester, PA, was given an official warning letter by the FDA about violations for failing to report adverse events occurring with patients, and kept selling pumps that Animas knew had parts requiring replacement. The warning letter, posted the FDA website, can be found here.
The danger, obviously, is that too little or too much insulin delivered to the body can be life-threatening. If the device malfunctions, then the risk of endangering the diabetic becomes all too real.
