FDA Warning Letter Cites J&J Unit For Not Heeding “User Error” Complaints
This article was originally published in The Gray Sheet
Executive Summary
Johnson & Johnson/LifeScan received a warning letter for neglecting to adequately follow up on frequent reports of user errors associated with its blood glucose meters
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Abbott glucose meter
Firm has received new reports of instances wherein its FreeStyle and FreeStyle Flash blood glucose meters in the U.S. "become inoperable or may revert to a reset condition," potentially leading to a change in the units of measurement and, consequently, misguiding therapy decisions. The July 20 announcement follows a related Class I recall in October 2005. Abbott has issued a letter to healthcare professionals and all customers potentially affected. Meanwhile, it reminds users to check each time they test to make sure the meter's display is correct. J&J/LifeScan has had similar issues with its OneTouch Ultra blood glucose meter (1"The Gray Sheet" Jan. 2, 2006, p. 5)...