The Food and Drug Administration (FDA) warned Abbott Laboratories’ (ABT) diabetes unit about manufacturing violations involving the company’s blood-glucose-monitoring systems, according to a report published on NASDAQ.com. The July 2 letter stemmed from a March inspection of an Abbott Diabetes Care Inc. facility in Alameda, Calif., that makes the FreeStyle glucose-monitoring and the Navigator continuous-monitoring systems. The devices are used by people with diabetes to monitor their blood-glucose, or blood-sugar...

Following the recent clearance of its FreeStyle Lite® blood glucose test strips, Abbott announced that it has also received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new FreeStyle blood glucose test strips. The new FreeStyle test strips minimize interference during blood glucose testing and are designed to offer a better testing experience. In a similar fashion to the FreeStyle Lite blood glucose test strips, the new FreeStyle test strips do not use the GDH-PQQ(1) enzyme, which can be affected...

Abbott announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new FreeStyle Lite blood glucose test strips. The new FreeStyle Lite test strips minimize interference during blood glucose testing and are designed to offer a better testing experience, meaning they will ensure faster blood application and reduce the number of error messages and wasted test strips. The new FreeStyle Lite test strips do not use the GDH-PQQ enzyme, which can be affected by common non-glucose sugars,...

I’m immensely interested in cosmology.  Headlines like this one, “The Circular Logic of The Unvierse,” in the NYT are sure to pull me in.   I won’t claim to really understand anything about the universe, though.  I mean, I learned a few things in college, like, despite the claims of Akkadian poetry, Babylon was not – in fact – the center of the universe.  And I know that Aristotle was wrong too; the universe is not geocentric. Artists Rights Society (ARS), New York/ADAGP, Paris Vasily Kandinsky, “Several...

I love my CGM, don’t get me wrong. But there are times when I run into problems with my continuous glucometer, like when it falls off during exercise, or when I rupture a blood vessel and bleed all over the floor (see here – but watch out; there are photographs). Perhaps unsurprisingly, Abbott — the maker of my CGM — got word of my bloody thigh, and sent me a note asking if they could put a customer service representative in touch with me before I lost any more blood — let alone blogged about it. I bring...

If you’ve clicked on this post, it’s probably too late to warn you — but I’ll try anyway: this post contains blood. If you don’t enjoy the idea of a dripping wound on your thigh, you might want to click back to the recipe section. It all started when I went to replace my continuous glucometer sensor last night (the same sensor to which I just declared my undying love). Yes, I know that the user manual for my Abbott Freestyle Navigator CGM says that you’re only supposed to wear the sensor on your...

I’ve been using the Abbott Freestyle Navigator continuous glucometer for about 10 months now, and in concept, I love it — it lets me see my blood sugar levels in near real time (okay, it lets me see my interstitial glucose levels with a 15-minute lag, but still). It has trend arrows, it has high and low alerts. Granted, its incessant buzzing sometimes wakes me up at four in the morning to do a recalibration (you have to wait 10 hours, which is ridiculous) — but still. I’m very glad I have it. And yet, I am...