Diabetes devices recalled, generics approved
Speaker issues were reported with an insulin pump and glucose monitoring system, and the first generic versions of exenatide and liraglutide were approved.
The FDA announced several actions related to diabetes recently.
First, a voluntary medical device correction was issued by Tandem Diabetes Care, Inc., for select t:slim X2 insulin pumps to address a potential speaker-related issue that can trigger an error resulting in a discontinuation of insulin delivery. There have been 700 reported adverse events related to this issue, defined as a confirmed high blood glucose level and/or an event requiring medical intervention, and 59 reported injuries.
There was also a class I recall of certain Dexcom G6, G7, ONE, and ONE+ glucose monitoring receivers because a problem with the speaker may cause it to fail to make an alert sound when blood glucose levels are dangerously low or high. There have been at least 56 related reported injuries.
In addition, two diabetes medications got their first generic versions approved: exenatide injection (brand name: Byetta) and liraglutide injection (brand name: Victoza).