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DexCom, Inc. (DXCM) Message Board

  • Im_in_here_for_fun Im_in_here_for_fun Oct 25, 2006 7:52 PM Flag

    Quality Issues

    So today a user posted that he had to replace two sensors in 5 months.

    This company can't survive if they are replacing their products every few weeks.

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    • Some seen in posts on Insulin Pumpers, where several people are in close contact with mfgrs.

      Some heard from my Endo, who has close contact with Abbott (and Minimed, and Accu-Check, and Animas, and Dexcom... he wears a Dexcom himself.)And finally, my wife is an MD and we have "friends".

      I haven't read *ALL* of the released FDA materials in these applications and denials, because I trust my Sources. But you should be skeptical, do investigate yourself.

    • Interesting info

      What is your source of info?

      Where can a customer or investor read up on this?

      Did you read all this on Abbott news, or is it rumor?


    • They keep changing their plans, because the FDA keeps rejecting their applications "unexpectedly".

      Back in June/July, they EXPECTED the FDA to approve their application in time for an August launch-- and they talked about it, loudly. But their initial application requested approval as a TOTAL REPLACEMENT for finger-stick testing: when the alarm would go off, you WOULD NOT have to check your bG with a "real" meter before treating it.

      The FDA said "nope, not acceptable". It's good, but it's not THAT good-- to many readings were in the Clarke Error grid areas "D" and "E", where a serious treatment error would be made. (Example: the Navigator says "95", but you're actually at "45". If you go out on the freeway in a rollover-prone SUV without eating sugar tabs, that's a BIG problem.)

      So Abbott submitted a new Application: without the "total replacement" usage, they EXPECTED the FDA would approve it quickly. So they started saying to all the newspapers (and any one else who would listen, "We're planning to be out before the end of the year, and we're gonna start a price war."

      But the application was rejected again, the FDA didn't want to accept a 5-day Sensor wearing period. (Abbott had ASSUMED that the FDA would rubber-stamp the application when the FIRST objection was resolved, this is not true. The FDA will typically stop at the first "fatal" problem in the application-- when that was resolved, they looked closely at additional stuff which they never even bothered to get to before rejecting in August.

      In this case, as they continued studying the device and its usage, they got all worried about infections having a full 5 days to "settle in" and grow before the pt. would remove the Sensor. REJECTED.

      Although some Marketing people are still issuing the Sep/Oct statements "we're planning to start a price war before the end of the year", and others are quoting the Wall Street Journal Interview from back then, Abbott has seen their application rejected.

      Currently, I hear, they are appealing the 5-day objection. But also, they are planning (based on the very likely refusal by the FDA to over-turn that decision) to accept a Sensor lifetime of only 3 days, same as Dex and MM. I don't know if that application is already in, or if they're waiting for the appeal process to complete.

      The rumour mill says that "release with only 3-day wearing" plan is scheduled for late January.

      Is that one gonna finally be true? * MAYBE. * The FDA doesn't "HAVE TO" accept even the 3-day application, they'll continue to assess it fully and see if they have other show-stopper objections before approving even that one.

      But, given Abbott's results of much higher accuracy and reliability, I'd be kinda surprised if it didn't go through.

      The question for someone like me is, can Abbott be "tricked" into more time the way MM and Dex can? If not, the increased Sensor costs are an almost total show-stopper. If the cost per Sensor is the same $35 as MM and Dex, $4200 per year versus $750 per year (with no insurance coverage) is a big thing.

      I hear that Dexcom's supposedly upcoming "7-day" Sensor (or "8-day" ?? I've heard both) can NOT be reused. So it would cost me about 2x as much, maybe even a bit more than 2x.

      Is it good for Dex to have the "elephant in the room" in suspended animation? Of course it is, when the elephant is unchanged an goes on a rampage Dex *will* be hurt. But Dex has apparently never even commented about all these Abbott Marketing/Management broken "promises". I think that's been a mistake, and I think they could win a few "fence-sitting" customers by pointing out these facts.

    • VERY interesting. The last I read, Abbott was gonna be ready by end of 06. Where did you read January?

      I suppose the longer they take the better for Dex eh?

    • "So today a user posted that he had to replace two sensors in 5 months."

      No, I had to do only two PURCHASES (total of 10 Sensors) in 5 months-- after they gave me 2 more in the start up kit and 3 additional when I had problems. I've used about 15 Sensors, sometimes they fail quickly (1 or 2 days) because I hit a capillary and the blood damages them.

      So your statement is off by about a factor of 7. Or are you referring to someone else? On all the diabetic message boards where I take part, I have (by far) the longest average Dexcom Sensor life, and I only get about 17 days. It's absolutely not credible that a Sensor could last for over 2 months.

      Still, the fact that DXCM isn't making anywhere near the $$$ from Sensors on customers like me is a huge factor in their ongoing losses, that's for sure.

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