This was not about a product issue but rather about documentation issues found during an FDA inspection. Could be from interviews or documentation on production, training, hiring, user calls, suppliers, processes, or qualifications. Not a product, I’m only guessing, but having worked at a med device manufacturer and experiencing multiple FDA inspections, this is pretty common post an inspection, which can be done at anytime by the FDA without an significant reason.
From the description and an online search to find the actual “items” warned about (I found virtually nothing), this could or could not be something of concern. Until further information is found it just doesn’t appear “knowable.” However, because its something we use daily and make life decisions with, it is somewhat concerning. The question is how much you trust Dexcom and the FDA. Seems if it was something medically important there would be more action, but something to watch and listen for…more to follow.
Thanks for the context. I just had another G7 fail immediately because of an incompletely inserted sensor wire, but it was manufactured in Malaysia, not either of the domestic plants. But I do wonder if the expansion is stretching their capacity to keep things running smoothly overall.