I order my sensors from CenterWell Pharmacy, 3 boxes of 3 sensors every 90 days. A few weeks ago, I noticed that a sensor was expired as I started the insertion process, but no I longer had the box it came in. Concerned about a repeat of that experience, I checked my most recent shipment upon receipt. All 3 boxes bore the same lot # (7367027) and expiration date (2026/12/31), but only 1 of the 9 sensors inside had this same information on its label. All of the remaining 8 sensors had different lot numbers, and of these, 2 had already expired on 2025/12/31. 6 will expire on 2026/12/31. Dexcom customer support agreed to replace the two expired sensors but didn’t have any explanation for the mismatch between box labels and contents. I advise fellow G6 users to check their inventory and new shipments carefully for this potential problem.
Thanks for that and Welcome to FUD!
wow, i will pay better attention now.
I’d recommend anyone experiencing what @BugsNBones describes file a complaint with the FDA regarding the discrepancy. Packing products with discrepancies of S/Ns, manufacture/expiration dates, expired devices, etc. is a danger to the intended product users and various FDA and FTC rules. It actually sounds like a “re-packageing” issue by a supplier rather than a Dexcom desire to use the entire G6 supply chain before terminating the product line; Dexcom’s image is on the chopping block of users and if reports of this become common, it could ruin the brand.
I had this happen from g6’s from Express Scripts in the last month or so and told Dexcom about it when seeking a replacement for a horrible sensor, and the rep was nonchalant and just said don;t worry about it. These are medical devices, so I just can’t imagine anything but nefarious business practices. We wouldn;t accept it for our groceries or any other item, so I just do not get what is going on. Just my 2 cents. . .
Thank you for the suggestion, @TomH. I have filed a complaint with the FDA, using the “Allegation of Regulatory Misconduct” form under the Medical Devices heading. This seemed like the best fit since it is apparently a failure to follow good manufacturing practices (the FDA’s wording). Link to the FDA site: SmartHub - Report a Product Problem
@Quadgirl Pardon if my comment sounded like I was excusing Dexcom from responsibility, not my intent; rather it was just a comment on a “perceived” most likely source of the problem. If it’s actually a Dexcom production issue, I agree with your comments completely!
It is not uncommon for different lot numbers/part numbers to be used throughout the mfg/packaging processes for medical devices. As long as there is documented traceability throughout the entire process - starting from raw materials to finished goods - it is perfectly acceptable. Internal manufacturing documentation shows all lot/part numbers used so that during an FDA inspection, you can trace back to all the raw materials used in the manufacture of each device. The more critical the device is, the more critical the traceability process is (eg individual serial numbers may be used in lieu of lot numbers).
So a single finished (and tested) G6 sensor would have a different lot number and part number than a packaged box of 3 finished (and tested) G6 sensors. The packaging materials, instructions for use and labels used to put the 3 sensors into a box would make this a separate mfg operation. Hence the need for separate lot/PNs.
This documentation is called the Device History Record and is required in accordance with FDA Good Mfg Practices (GMPs)
However the expiration date on the outside of the box of 3 sensors should always match what is on the inside of each of the individual sensors. Failure to do so is a violation of the GMPs and actually renders the product mislabeled.
Hey, Tom! No, no, no - I am the one who needs to ask your pardon! I am guilty of just scanning, and saying that somebody finally noticed the same thing that happened to me, and it never occurred to me it could happen to somebody else, or that other people might look at the box versus the contents of what was a sealed box and look at the dates and production lots. So I just immediately sat upon ranting about Dexcom. That was very sloppy on my part. I am just so appreciative that you even brought it up. I really really really did not expect anybody to ever noticed that. So my apologies for being sloppy, but thank you so much for posting! At this point, it’s just a moot point, but just something to consider as we go forward and see how companies may change or not. It just seems like such a different company than when I started five years ago. Anyway, I’m so sorry that you had to take time and address me. You have always been so helpful to me here so please accept my apologies. And thank you!