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Omnipod Users: New freestyle butterfly strips readings are inaccurate

Discussion in 'Parents of Children with Type 1' started by TRICIA4, Oct 18, 2010.

  1. Kayeecee

    Kayeecee Approved members

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    In the 'for what it's worth category': I freaked when I read this thread, so I tested the same drop of blood with two different butterfly test strips in both the Omnipod PDM and on the Freestyle meter. Pod: 87 Freestyle: 93

    I'm going to be cautiously optimistic about the PDM for now. I note for the record that we have a relatively new PDM; it was replaced about 90 days ago. Don't know whether that might make a difference.

    ETA: The Dex said 103 going down.
     
  2. TRICIA4

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    We are using LOT 1021013 code 16, different from yours, and having inaccuracies. Anyone else having problems, have this same LOT #? We have 7 boxes of the new strips, and they are all the same LOT #. So I cannot compare.

    Our PDM is the new style, but is 13061-AW Rev D
     
  3. khannen

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    We are using lot # 1021114 and having inaccurate results.
    Our pdm is 13050-AW Rev B and I think we've had it at least a year.
     
  4. TRICIA4

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    We have had our PDM for at least a year too...I will call tomorrow and see if I can get a new PDM. It's worth a shot!
     
  5. khannen

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    Just did a test comparison

    Used a backup Freedom Lite meter we had with FL strips and got 246
    Omnipod pdm with new freestyle strip? 198
    Navigator said steady at 242

    Yeah... so not cool
     
    Last edited: Oct 19, 2010
  6. swellman

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    Does the Navigator have a built in meter? Do you calibrate it from the results of the PDM? Or another meter?

    I have to be honest and say that this really confuses me - not just your post but others who have used a CGM to support their claim of inaccuracies. I have to commend those who have such faith to question a BG meter based on a CGM. We've been using the Dexcom for some time now but I would never, ever, ever question a meter based on the Dexcom - that's just our experience.

    One more thing, if you're (general use) not comparing PDM vs Freestyle with Old vs New strips then there's just not enough data to conclude anything IMO. There should be 4 readings - 1 set from one finger stick and the second set from a very close time frame second finger stick and I would go so far as to suggest the same finger. Codes should be guaranteed changed. Under these conditions one would expect to see 3 close numbers and 1 "off" number and that one off would need to be the PDM on New strips.

    Lastly, and I know you won't like it, but the 246 vs 198 is within the accepted margin of error as I understand it.
     
  7. lil'Man'sMom

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    On the phone with Abbott right now. I am on hold...go figure, 12am and all.

    Anyway, I don't have our FS meter here, it's at school, so I used the FSL. Tested with new butterfly, yellow label, strips in PDM and FSL, reading was 146 and 145, respectively. I realize the box on the FSL meter states to use with lite strips only, if they are not compatible, I am curious as to why I am getting the same reading. This was my second question to Abbott.

    My first question was the strips not being FDA approved for use in the Omnipod PDM. They are not, and of course Abbott could not give me answers as to why or when, just that they are not FDA approved and we should not use them with the PDM.

    I am going to get the FS meter from school tomorrow and do more testing. This really sucks, we have been using the new version since August. We ALWAYS use the PDM for testing, will have to continue to do so until tomorrow afternoon when I can get the meter from school. I have no other test strips on hand.

    I will be calling Insulet first thing in the morning. The CSR at Abbott told me to call her back tomorrow evening when I get the FS meter and do some comparisons. I think I will call during the day time hours, when they have a full shift of tech. people on hand. She was very puzzled at my meter readings with FSL meter, using FS (new version) test strips, being dead on with my PDM.

    Tomorrow is going to be a long day....
     
    Last edited: Oct 20, 2010
  8. jill

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    Test results from last night with Control Solution and code changes:

    Freestyle Lite w/lite strips (leftover from before switching to Omnipod)
    107

    Flash Meter New Strips 82
    Flash Meter Old Strips 110

    PDM New Strips 86
    PDM Old Strips 111

    We are using lot #102506, but picking up a new round today from CVS, will do the same tests and see how they go. Our PDM is very new - August 25.

    I spoke with Insulet last night regarding a pod issue and then mentioned the strips - they again told me not to use them and told me to call Abbott to have them send me more strips, when I shared that I already spoke with them and they could not send me more strips, she told me she would overnight me 100 test strips and pass my name along to Abbott tomorrow.

    Could it be that the new strips are that much better/accurate?? I am so confused!!
     
  9. Kirsten

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    I think all of you are suddenly realizing how inaccurate test strips actually are. They are allowed to be +/- 20%! I have faith in the new strips, FDA approved for Omnipod or not.

    My 2 cents!

    Kirsten
     
  10. buggle

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    I totally agree. Any BG test is just an estimate -- sometimes they are off by quite a bit. It's better than the old boiled, test tube, urine testing, though. :)
     
  11. khannen

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    Yes and no for me here. I knew they could be 15-20% off, but for EVERY test comparison? 20% of what? When she woke up this morning. new strips in the pdm read 87. A Freestyle lite test with the same drop of blood read 134. I had both meters ready and waiting so the time delay was literally a second or two. I'm not good with math, but 20% of 87 is around 17 or so. 87 plus 17 is 104. 20% of 134 is 26. 134 minus 26 is 108. To me, that is MORE than 20% off but perhaps I'm looking at the whole thing in the wrong way. Please explain if I am! :)

    I did a second set immediately after and got 86 on the pdm and 132 on the FSL. Navigator read 131 during all of this.
     
  12. jill

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    I agree - the test is just an estimate...I just wish everytime was not off. After talking about it last night and doing the various tests, we agreed that the new strips are fine and the FDA approval is probably a paperwork issue.

    Ironically, I just picked up our prescription from CVS and it was a mix of old and new strips :).
     
  13. khannen

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    I have no old strips to use or I'd be comparing with those as well. Yes codes are correct. I addressed my understanding of the accuracy range in a post just moments ago. I thought it was 20%
     
  14. Melissata

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    I just did comparisons with old and new strips with a huge drop of control solution, changing the codes as needed.

    101 with old strip
    91 with new strip

    95 new
    111 old

    Close enough for me, who knows which one is more accurate? New strips are reading about 10% lower. Since my daughter is hypo unaware, I will have to keep this in mind. I do test her PDM against the lab and it has always been very close.
     
  15. annaluvspink

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    It's always good to question the validity of any test strip. The 20 % error +/-has always reminded me that the blood glucose number is always just a snapshot in time with that particular blood sample. Scary, but true.
     
  16. ecs1516

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    So are the new strips accurate if we use them in the Freestyle Lite meter? Just not in the Omnipod?
     
  17. swellman

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    I, too, agree that what we are most likely seeing is a combination of several things. I think it's likely that the new strips are, in fact, more accurate. In fact, the press release by Abbott stated so - especially in certain conditions and with certain medications if I recall correctly. It uses a different enzyme, I think.

    Secondly, we are realizing that ALL meters have error. They have meter to meter error and test to test error. I think it's entirely possible, and very likely, that some meters read higher or lower than others.

    It's also possible that we are realizing the reality of what +/- 20% really means. If you look on the new strips you will see they added two additional ranges for calibration solutions - which I can't find locally but will probably call Abbott and ask for.

    Low: 40-70
    Normal: 83-125
    High: 248-372

    Note the 30 point range in the "Low" range, the 40 point range in the "Normal" range and, get this, the 130 point range in the "High" range. Any time your meter reads within this range with the control solution your meter is deemed calibrated and within specifications.

    As a bench and analytical chemist I have made more measurements and conducted more tests that I can even begin to count and I know full well about variability even in extremely accurate instrumentation and I allowed myself to get sucked into the mentality that the number coming out of the meter was gospel. Without doing a precision and accuracy AND TEMPERATURE (also a factor) experiment we will never know, beyond the control solution ranges, how accurate any of our meters are.

    Even before all of this strip mess I was starting to wonder if my PDM read a tad higher - our last A1c was 6.3 which corresponds to an average 134 and my meter showed an average of 147 which corresponds to an A1c of 6.7. Of course all of this I have here is within 10% RPD and the difference isn't really meaningful in the crap which is diabetes.
     
  18. TRICIA4

    TRICIA4 Approved members

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    I'm not sure I am understanding this new calibration system. Please give me an example of what it means if my meter reads in the "low" range. Does that mean my meter is reading low? I calibrated with the new strips with the PDM and it read 82. The calibration with the old strips read 91. I just want to make sure I am understanding this correctly.
     
  19. swellman

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    There are three different control solutions now available (for all I know they were always available) - Low, Normal, and High. When you use the Low solution you use the Low range, etc, etc.

    Just to be more clear - When checking to see if you meter is accurate in the low range you use the Low solution and check the numbers against the calibration range for Low - if within the range your meter checks out. Same goes for Normal Solution and Range and High Solution and Range.
     
  20. virgo39

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    I spent several hours on the phone Tuesday with Insulet, Medco, Abbott, back to some again and then left a message with Mini Pharmacy (phonetic) that Abbott referred me to replace some strips.

    Finally spoke with the pharmacy rep today, who referred me back to Abbott customer care, assuring me that in the last 2 days Abbott had set up processed to handle this and Abbott was now on top of this.

    They seemed to be. Just got off the phone with Abbott, which is replacing 500 of the 1,000 (butterfly-FAD) strips I have next week and will contact me about replacing the remainder. (Pharmacy rep referred to non-butterfly strips as "PQQ strips").

    I also did my own unscientific comparison yesterday -- using the same drop of blood each time:

    A.M. (fasting)
    Accu-chek Aviva meter: 138
    Omnipod with Freestyle (butterfly-FAD) strips: 138

    After school (3 hours since lunch):
    Accu-check Aviva meter: 119
    Omnipod with Freestyle (butterfly-FAD) strips: 42

    I do not believe that the 42 reading was accurate. DD seems to be aware of low blood sugars and said she felt fine.

    So, if you are having issues on this, it might be worth another call to Abbott customer care.
     

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