Oh the irony
Just weeks before the FDA panel meeting on blood glucose monitoring, LifeScan this afternoon announced a voluntary recall of OneTouch® SureStep® test strips. According to a company issued press release; “LifeScan, Inc. is conducting a voluntary recall in the United States of eight lots of OneTouch® SureStep® Test Strips, used by people with diabetes to measure their blood glucose levels at home. The test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL.”
The truly ironic aspect of this recall is not only does it come just a few weeks before the FDA panel meeting but it comes as LifeScan has been aggressively touting the accuracy of their test strips. The SureStep is one LifeScan’s older products and does not use the OneTouch Ultra Blue test strips which they claim are more accurate. However, it does seem just a tad ironic that a company who claims their products are more accurate is recalling test strips because of inaccurate readings.
The irony becomes even greater when you visit the company’s web site which contains a letter which states; “We have recently determined that up to 900 OneTouch® Ultra® Test Strip Packages contain vials of the wrong test strip. These incorrect test strips can be easily identified because they are dark blue and don’t have a brand name printed on the strip (See Picture 1). As a safety feature, these strips will not turn on your OneTouch®Ultra® Brand meter or provide a test result.”
Also back in November of last year there was another notice from the company which stated; “We have recently determined that two lots of 100 count OneTouch® Ultra® Test Strips may contain a small number of damaged test strip containers (also called ‘vials’). These test strips were sold in 100-count packages containing 4 vials of 25 test strips each.”
Granted these issues are not earth shattering and LifeScan should be commended for taking the appropriate steps to inform their customers and physicians. Still, there are surly some in the BGM community who are getting just a little laugh from these events. It was LifeScan after all who pushed the FDA on the PQQ issue and has made test strip accuracy the cornerstone of their new marketing strategy.
Diabetic Investor has always held the belief that the accuracy of a test strip is an overblown issue for 97% of the diabetes patient population. Not that we don’t want to see more accurate readings rather that for most patients the current crop of test strips, even with their flaws, are good enough. As we have reported before there are several factors that go into calculating how much insulin to dose and glucose results are just one piece of the puzzle.
The second issue we have with accuracy is that it is a measurable target, in that; once the standard is set and everyone meets it you lose any marketing advantage. As we reported before LifeScan’s strategy of promoting greater accuracy is truly a stroke of genius as it puts their competition on the defensive. However, this perceived advantage will go way once everyone is held to the same standard.
Finally, and today’s recall is fresh evidence of this, when you claim to have the most accurate test strip you better not screw up, even when the screw up is not for strip your promoting as super accurate. This would be like Toyota telling people that they build the safest cars on the road today. Thankfully for LifeScan their recall will not prompt a Senate investigation, well maybe not- these days you never know.
