Abbott Diabetes Care

Discussion in 'Abbott' started by Anonymous, Dec 18, 2009 at 6:59 PM.

Tags: Add Tags
  1. Anonymous

    Anonymous Guest

    Re: FDA Observations at Abbott Diabetes Care

    I know the previous poster and can assure you that she is a Freestyle Navigator user, as are both my son and daughter. We are also without the product, and this is the second time around for us. The same thing happened last year where there was a supposed inventory interruption and know one knew anything. We are just looking for answers on what to do, give up on Abbott ever getting their act together and move to a different CGM or hope that it gets better. None of you can possibly understand how it is to live with this disease 24/7 and finally find something that makes it a whole lot easier, just to have it be gone again in an instant. We were waiting for the upgrade that was going to make it an even better product, and now we have no idea if we will ever see that, or even get a replacement product. I guess that we have come to the wrong place for help. Insurance companies do not approve these things without a fight and Abbott doing this to us again is not going to help with that either.
     

  2. KellyWPA

    KellyWPA Guest

    Re: FDA Observations at Abbott Diabetes Care

    I decided to register with a user name to show you that I am really a customer. I am the person that posted #36, however, I am not the person that posted “you caught me” nor am I the person that copied my post into the other thread. My having a user name will prevent that game from being played. I use this same username on the ADA message boards & TuDiabetes. I also have a blog with this username on WordPress. I have written about my Navigator problems at all three places.
     
  3. Anonymous

    Anonymous Guest

    Re: FDA Observations at Abbott Diabetes Care

    Kelly, sorry to hear about the problems you are having. Have you contacted ADC directly? HQ is in Alameda, CA. Or perhaps your doctor can get you the name of a local rep, who can then get you to their region manager. Hopefully you will find answers there, as well as people who care and can help.

    This board has been referred to as the bathroom wall at a bus station for good reason. It is not a place to get serious responses to anything.
     
  4. KellyWPA

    KellyWPA Guest

    Re: FDA Observations at Abbott Diabetes Care

    Thank you. I have been talking to someone in the corporate office. Unfortunately, Abbott is being very closed-lipped about what is going on. I don’t know if the post about the FDA was true or not but since Abbott is not saying why everything is at a standstill, that post looks true to those of us sitting here waiting almost 2 months for a replacement and not getting answers as to what is going on. The sad part is, I do believe the Navigator is the best CGMS on the market.
     
  5. Anonymous

    Anonymous Guest

    Re: FDA Observations at Abbott Diabetes Care

    Kelly, I hope that you get a quick resolution to this. We are all sorry for this inconvenience.
    I have never known anyone to identify themselves on this board. I will warn you that there is a lot of misinformation on here, so it is best to stick with talking to Abbott corporate or finding your local representative. I really have not heard any of these issues. but if I did I would not post them here, I would work closely with the patient and Abbott. I come here for entertainment only.
     
  6. Anonymous

    Anonymous Guest

    I am also a user of Navigator.

    I have been without a transmitter since 2/14 (vday).

    Abbott first promised to ship one out in two days. Then they said 3/8 due to "inventory interruption". Now they are saying "we don't know". And not a single person there seems to know what's going on. I've been talking to John Rome, who has been very nice, but nice doesn't help me at this point. I need an answer. At this point they have been sending me 200 strips every couple of weeks to keep me going. How long until that stops too?

    Going on the Navigator was an amazing change for me in terms of my care. I was on it for 15 months, and had seen the number 300 come up only twice in that entire period, and had been able to avoid numerous massive hypos (my big problem historically). My A1C's dropped to 6.7. In fact, the device did everything it was supposed to do, I was a textbook case of the kind of patient that would benefit most from every aspect of the unit. I turned several others onto this and I know of at least two managed to get coverage through insurance for it. Now I speak to them and they have it and I don't.

    My Freestyle Flash is testament to how my control has deteriorated, and how quickly, since mid February. I've had over ten days of 300+ wakeups, following nighttime low BG episodes. At least once I bit my tongue painfully when my jaw locked on it during one of these. I've gained 6 lbs due to the massive intake of calories that come as a result of dealing with additional hypos - those chocolate bars and cookies and orange juice bottles add up, although I am certain it also has to do with the slight depression I have developed as a result. I'm feeling tired and lethargic and find myself crying with no reason (like now as I'm writing this). I just did my blood tests and if my A1C is not at least 0.5 higher, I'll eat the proverbial hat.

    I can't do this anymore. I don't know what to do. Abbott simply doesn't care. They don't CARE! as far as they are concerned, I can die. I know it's not true, but that's how it feels. Yes, Mr. Rome has been nice enough to me on the phone. But I'm the one who is sick. I feel so helpless. And they... don't... give... a... damn.
     
  7. Anonymous

    Anonymous Guest

    Sorry for your situation. Look into either medtronic diabetes or Dexcom.
     
  8. Anonymous

    Anonymous Guest

    Thank you.

    I was on the Dexcom 7 before I got the Navigator. It helped somewhat, but it didn't work well enough for me to gain a big enough benefit. The main reason is that 5 minute interval. Unfortunately, when my blood sugars drop, they sometimes drop super-fast (100mg/dl in 15-20 minutes is not that unusual). The Dex at that point simply doesn't work; it refuses to show a result when the drop (or rise) is too fast, which means that I could go 30 minutes without getting a reading, miss the hypo, and only get a result when I was rebounding.

    The Navigator at least always shows a number, and it checks every minute so I can "catch a dropping knife" if you will. The results were clear; a year on the Dex got my A1C's to 7.2 or so, but still with quite a few spikes and drops. A year on the Nav got me down to 6.7 with a much flatter distribution.
     
  9. Anonymous

    Anonymous Guest

    Ask your doctor who there Minimed/Medtronic Rep is and contact them directly. Are you on a Insulin pump? Medtronic is way ahead of everyone else with regards to CGMS. You could also go to their website and contact the company directly. They also have a blog on here under Medical device section/Medtronic and you could get a lot of info by leaving your situation on their board. You will have to screen through all the negativity. Everyone attacks everyone on here to vent and because it is Anonymous. I don't work for either company but I
    am in meter sales. What city do you live in and I can get you the local Reps name and number if you wish.

    Good Luck.
     
  10. Anonymous

    Anonymous Guest

    Hey LifeScan. Have they fixed the accuracy issues with the the Medtronic CGM?
     
  11. KellyWPA

    KellyWPA Guest

    Re: FDA Observations at Abbott Diabetes Care

    I can see that everyone posts anonymously here, but I figured by registering with a user name, I could prove I was really a customer and people can’t play games with my posts.

    Unfortunately, the people at Abbott aren’t saying anything except they are sorry. This is more than an inconvenience; this is a medical device that people depend on - this is literally my life that Abbott is playing games with.
     
  12. Anonymous

    Anonymous Guest

    Nope, not on a pump, and don't really want one. That's why I stayed away from Medtronic - my understanding (maybe erroneously) is that their standalone CGMS is not that great. And it also suffers from the 5m interval issue (right?). The Nav AFAIK is the only device that gives a reading every minute, and it does matter to those of us whose blood sugars often go wild VERY rapidly.
     
  13. Anonymous

    Anonymous Guest

    MDT system is as good as any. There sensor will get a six day indication and is every bit as accurate as the Navigator. You will have more service from Medtronic than Abbott and is evident by the high turn over in Navigator reps, i believe there is less than 15 in the nation.
    5 min interval is not a issue at all and no study has shown either to be statistically better than the other. Go ask your CDE for their opinion and also ask what company will better serve you once on a product.
     
  14. Anonymous

    Anonymous Guest

    Um... "5 min interval is not an issue"?

    That's a rather insensitive statement. Like I SAID, it is an issue FOR ME. No study was ever done ON ME, you know. I am a documented case (to the point where UCSF endocrin labs had me speaking several times to 40 doctors at a time about my diabetes) of "extremely brittle". 5 minute intervals ARE MOST CERTAINLY an issue for me. When my blood sugars can and often do drop 60mg/dl in 5 minutes for no apparent reason - well documented in lab tests - that's an interval that is too long.

    "Statistically shown"... sheesh. Since when did "statistics" apply uniformly to every individual element?

    No, I'm not interested in the Medtronic or the Dex exactly because of this "non-issue". Having spent a year on the Dex and seeing how important it is FOR ME, I am not going to go through the long, complex, and difficult process of getting approval from my insurance company for a device that doesn't work the way *I* need it to work, as long as there is a chance that the device that DOES work the way *I* need it to work will be given to me again.

    Anyone here from Abbott?
     
  15. Anonymous

    Anonymous Guest

    Try the Abbott Medical device board. This Thread is for the meter division who are clueless about meters much less CGMS. Most of them wouldn't know what CGMS stands for:)
     
  16. Anonymous

    Anonymous Guest

    I am a Navigator user. I am also a physician. I do not work for a pharmaceutical company. I do not eat pharma food or give talks for pharma companies. So you probably know my bias at the outset.

    I switched to the Navigator at the very end of January 2010. I was a long time Medtronic user but got those defective lot 8 infustion sets and wanted to try a new company.

    When I first started using the Navigator, I had trouble calibrating it consistently. Then I had periods of time when it gave me readings that were way off. My husband was very concerned about the bad readings so I inserted my old Medtronic CGM and ran them simultaneously. I got better readings with the Medtronic unit.

    I had the transmitter fall off my arm twice. The adhesive bandages that give you to help make the transmitter stick do not work and are the wrong size. Customer services admits this. I was able to manage a work-around by using two smaller adhesive bandages but obviously Abbott is not able to figure out something as simple as this.

    I tried to use the Copilot system to load the data on my computer but it seems to have problems with Vista.

    I tried to use the receiver's belt clip but it kept falling off so I kept the receiver in my pocket. It fell out into the snow and the small amount of dampness it got before I scooped it up, killed the receiver. Thus all of my data was lost.

    I called for a new receiver and was told that they would ship me one before I left the country. When I called to see why it did not arrrive, I was then told that the product was not shipping. They will not give any estimate about when it will ship.

    Between the very bad readings, and the way Abbott is stonewalling us, I think that our only recourse is to complain the the Medwatch section of the FDA. I have posted the link to the FDA's complaint page on a diabetes message board.

    I hope Abbott administration is reading this. I did not do this lightly. I made a lot of calls to Abbott first.

    I am hoping that Dexcom will have an integrated unit soon.
     
  17. Anonymous

    Anonymous Guest

    Poor Customer Service at Abbott Diabetes Care

    I agree with the healthcare provider's (#56) recommendation that patients who have issues with the Navigator should contact the FDA via MedWatch. He mentioned an incident about his Navigator falling in the snow and then becoming useless. In fact, if you check the FDA website, you can find a malfunction issue with the Navigator (Case #70684-02), wherein cracks were discovered in the thermistor barrel, thus letting moisture get into the system. Obviously, if current customers are not getting any support nor replacement transmitters in the past two months, then something must be going wrong that the public is not privy to. Another insightful information from the FDA website, as well as ADC's website, is that the Navigator uses the FreeStyle test strip, which has an enzyme that can give falsely elevated readings since it can interfere with other sugars, such as maltose and galactose. Roche uses a similar enzyme, but Lifescan, Bayer, and other companies use a different enzyme that do not cause this interference. Please check out this safety message, which is in both the FDA and Health Canada's websites.
     
  18. Anonymous

    Anonymous Guest

    Physician from #56 again:

    Abbott customer services reps do not seem to be aware of the issue of the test strips and the potential interactions with other types of sugars. I called about this issue to see what they would say. The rep was unaware of the GDH-PQQ issue. When I pressed him on it, he consulted someone, and I think they looked through some manuals. Evantually after several long periods on hold while something was going on, he came back and said that the strips did have the GDH PQQ. I asked why Navigator users who have to sue these strips were not sent advisories on this or warnings about chewing gum certain drugs etc. I mentioned the FDA.

    After MORE checking and time on hold, I was told that they did have a protocol for talking to patients about this issue. Apparently if a customer calls and complains about unusual high glucose readings, they are supposed to say something about the GDH PQQ issue. Of course, in order for the rep to say something about the strips, he would have to know about the issue in the first place. The poor rep felt bad after talking to me. I told him that it was not his fault, but that he should insist that his supervisors give them more training about this issue.

    The issue was escalated to someone higher up who is suppsed to call me during business hours. Because I am a health care provider, I am probably in a better position to know about this type of issue. But what if I really had an acute problem with high glucose readings related to chewing gum or something? Would I have to wait until Monday to get a call from someone who at Abbott who understands the GDH PQQ issue?

    Again I hope that someone from Abbott's administration is monitoring this. Your reps should know about this issue.
     
  19. Anonymous

    Anonymous Guest

    Re: FDA Observations at Abbott Diabetes Care

    I am also a parent of a child with diabetes... He has been using The Navigator for almost 2 years.. I must say that I'm very frustrated with the responses I get when I call customer service. No one has a clue about the calibration errors... I can actually hear them turning pages( actually search their computers) for the answer...... and god forbid I should ask about the upgrade?? I don't understand why no one knows anything???

    2 Children from the children with diabetes online list have died in the last week from low blood sugars...
    My son depends on this device for his life. This is a great device, why don't the reps or cust service people have any answers as to why its on backorder?????? or when it will be available??
     
  20. Anonymous

    Anonymous Guest

    If you google "FDA GDH-PQQ " you can read the FDA alert and all the issues around the enzyme.