We love a surprise. Regulatory letters rarely bring exciting gifts. Is this one? We spotted this warning below in a very recent FDA 510(k) approval for a meter. It is labeling that we have not seen perviously. Could the FDA have a new tool to help us StripSafely? We do not yet fully understand
From https://www.abbottdiabetescare.com/press-room/2013/2013-h.html: November 27, 2013 ABBOTT PARK, Ill., Nov. 27, 2013 — Abbott today announced it is initiating a voluntary recall of 20 lots of FreeStyle® and FreeStyle Lite® Blood Glucose Test Strips in the United States. These lots of test strips may produce erroneously low blood glucose results when used with both “FreeStyle®
Look what came in the email. Wouldn’t mobile diabetes apps that used a common data format and talked to ACCURATE meters be Groovy? — JOIN UPCOMING TWITTER CHAT — For Immediate Release FDA Twitter Chat on Mobile Medical Apps #FDA has info to share about mobile medical apps! Join us for a Twitter chat: 3:30 PM EST
‘Violent Agreement’ on Need for Monitoring Meter & Strip Accuracy. http://www.diabetesmine.com/2013/09/violent-agreement-on-need-for-m…
Here is video clip of our two cents at the Diabetes Technology Society meeting:
This piece in the New Your Times paints a troubling picture of gaming the system of Walmart overseas factory inspections. I would love to know who makes more of an effort to inspect overseas factories Walmart or FDA. No question the processes of FDA and Walmart are different. Still this articles does raise questions
On Wednesday, August 21st beginning at 8pm Eastern, we are staging a StripSafely Tweet-In, asking Congress to send aides to the upcoming Diabetes Technology Meeting on September 9th, where the testing accuracy problem will be discussed. Please join us and add your voice. We’ve made it easy. Simply go to the Let’s Tweet page of Stripsafely.com, find your
From our friends in New Zealand:
Thanks to Larry Ellingson for sharing this: RESOLUTION ON THE IMPORTANCE OF NEED TO DEVELOP MORE STRINGENT ACCURACY REQUIREMENTS FOR BLOOD GLUCOSE MONITORING SYSTEMS WHEREAS, the American Diabetes Association estimated in 2011 that 25.8 million children and adults in the United States have diabetes,1 and WHEREAS, the prevalence of diabetes has increased by 82.2% since
The following link will take you to letter from the FDA to diabetes device company. It would appear that medical device reports should have been filed when meter failed to report lows. Here is a little quote that makes it clear why we need to StripSafely: Complaints 618, 779, 728, and 818 describe events in which