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29 Responses

  1. StephenS
    StephenS April 17, 2014 at 8:05 am | | Reply

    Mike… great report. Thanks for doing all this tedious research. Makes me want to look into these companies a bit more. Thanks

    1. Andy
      Andy April 21, 2014 at 9:23 am | | Reply

      Stephen and Readers,
      I’m disappointed to see the inaccuracies and incompleteness in this reporting. As Brent commented about the Taiwan reference, the author’s bias and negativity toward these products is very apparent. As General Counsel to both companies, to whom the author refers, I feel the need to comment on the misrepresentations in this article.
      I continue to be astonished by the constant DOC attacks on Prodigy Diabetes Care, all arising from a FDA inspection in 2012 that did not include product defects or accuracy issues. The volume and tone of these attacks seem to be more in line with the marketing departments of the Big 4 than with unbiased reporters and patient advocates. I haven’t seen a single article (other than a simple posting of the release) by this community that has raised general corporate or manufacturing concern about the THIRD recall of products by one Big 4 manufacturer in less than one year, let alone the multiple worldwide product recalls, and the practices reflected in pricing and other marketing investigations.
      It’s not just Prodigy that says the 2012 inspection matter has been resolved, but the FDA conducted a full, unannounced inspection of Prodigy, and has posted a “closeout letter” on its website. Prodigy provided a copy of the Closeout Letter to the author prior to publication of this article. Instead of applying a negative spin on this issue, the author could have noted that the FDA grants closeout letters to fewer than 20% of the companies that receive warning letters, and highlighted the positive steps taken by Prodigy to address the FDA concerns.
      The author questions the accuracy of UniStrip1 test strips, but fails to provide any basis for doing so. The test results of the UniStrip1 with the J&J meters is public and available. As one of the commentors stated, the author could conduct a comparison test if the actual accuracy was important. (but a comparison test should be done properly) Instead, all the reader got was negative comments about the possibility that UniStrip might not be accurate. As for post-market surveillance, OK Biotech tests every lot of strips that it manufactures, and has used world-renowned labs to conduct third party tests of its products. No recall of test strips or meters manufactured by OK Biotech has been required — can you say the same for the Big 4 manufacturers?
      The statement that Prodigy is “putting out questionable quality” in reference to a different Prodigy meter is patently false. I personally informed the author, prior to publication of the article, that, upon clearance of that meter by the FDA, Prodigy immediately notified the FDA that it would NOT market that product in the USA, and has not marketed that product. As with many products that arise from R&D and market tests, that product was terminated. To use it as the basis for a “questionable quality” comment and smear is wrong. And then applying that to a different company is reckless.
      For those readers interested in facts, OK Biotech is certified under the worldwide ISO standard for medical device manufacturers (13485) by the largest third party inspector in the world (TUV SUD), which is accredited by all EU nations and the FDA for third party audits. OK Biotech has been audited and certified by Canada’s health agency. OK Biotech has also been inspected and certified by the Health & Welfare agency of Taiwan, one of the most advanced manufacturing nations in the world. OK Biotech similarly has invested in high-tech facilities, and opened its new state-of-the-art plant in May 2013. OK Biotech uses the same types of chemicals and components used by the Big 4 (most of which are also obtained and manufactured overseas).
      What should seem “shady” to caregivers, people with diabetes, and family, is that the Big 4 manufacturers have kept pricing in the USA at more than $1 per test strip for soooo many years, but sell the same products in Central and South America at prices comparable to that of UniStrip1. Look at pharmaceuticals—generic producers have brought billions of dollars of savings to the public in the area of drugs. The big pharmaceutical and device companies will continue to reap billions from all of us as long as they don’t have competition….and negative articles without thorough investigation will continue to support them in doing so.
      Lower price does not mean lower quality.
      We invite all of the readers of diabetesmine and stripsafely, as well as all people with diabetes, to be the judges of UniStrip1 by UniStrip Technologies, and of Prodigy Diabetes Care products. These companies offer quality products at lower prices.
      Or, you can keep paying more than $1 per test strip, substantially higher insurance premiums, and know that the big pharma and medical device companies are secure.

  2. Brent
    Brent April 17, 2014 at 8:19 am | | Reply

    I’m a regular reader of ‘the Mine’, and have a couple of issues with this article.

    Yes accuracy is a concern, but cost of test strips is an equal concern. We’ve all been screaming about the non-availability of generic test strips forever, and now it seems you are pooh-poohing it right when these are coming out?

    These strips were approved by the FDA and so would be at least as accurate as the current strips for the OneTouch meters for 10% of the cost. That is HUGE, particularly for some of us whose insurance is now limiting the number of strips they’ll pay for in a month (mine is 207).

    Also, the veiled xenophobic reference to Taiwan was cheap. Taiwan (different from mainland China) produces some of the highest quality electronic and scientific equipment anywhere in the world.

    More information on generic test strips would be appreciated. Will these work with the Link meter for Medtronic? Are they working on generics for the Bayer Contour next meters (also linked with Medtronic)?

    Thanks!

    1. Hallie
      Hallie April 17, 2014 at 9:49 am | | Reply

      Thanks, Brent, this is spot on!

      There are many people with diabetes who currently don’t have access to test strips, or at least don’t have access to enough test strips, due to their high cost and to insurance limits. Even IF these test strips had reduced accuracy compared to the brand names, they still give you a lot more accurate picture of your blood sugar levels than you get when you don’t have test strips at all! I, personally, am very excited about this development and only hope that many more companies follow with generic test strips in the future.

      1. Tim Steinert
        Tim Steinert April 18, 2014 at 1:22 am | | Reply

        I don’t agree that reduced accuracy with more quantity of strips would give you a better picture of your blood sugar levels.

        I just had a sub-par A1c and trying to wade through the reasons why it happened would make Columbo envious of my powers of deduction.

        I had what I considered to be good numbers by the meter (and up to 5 a day!), but the picture the readings painted was inaccurate and had me scratching my head for a long time. The fewer variables I have to wade through the better. I came up with the brilliant idea of asking my endo if his medical group has a professional CGM that I can use to figure out what’s going on (and slyly check my strip accuracy in the bargain). Thankfully, they do have a few CGMs and that data will help me track the problem down–but not everybody has access to the technology and have to depend upon strips alone.

    2. Andy
      Andy April 21, 2014 at 11:58 am | | Reply

      Brent,
      the UniStrip1 test strips are cleared by the FDA for use with the LifeScan OneTouch Ultra, Ultra2, UltraMini and UltraSmart. They are not cleared for use with any other blood glucose meter or system.

  3. mcityrk
    mcityrk April 17, 2014 at 3:36 pm | | Reply

    Seems like for the currently low entry price on these strips that a multiple daily tester could run their own comparison studies of these new generics against their current strips simultaneously and come to their own conclusions as to whether they can be trusted. Of special interest of course would be the accuracy at both the low and high ends of the curve where inaccuracy is most problematic.

    1. Dawn's Daddy
      Dawn's Daddy April 17, 2014 at 6:04 pm | | Reply

      Actually low end accuracy has not been a big problem for electro-chemical meters and strips since they were first introduced in the 1990s. It is the high end accuracy that presents a problem where the amount of glucose released chemically from the sample in reaction, adheres to the working strip electrodes with higher concentrations, usually beginning at 160-180 mg/dL creating a situation where the amount of free adherence space becomes more and more limited. Engineers that design meters call this noise, and the noise levels lower accuracy for higher end readings.

    2. Andy
      Andy April 21, 2014 at 9:14 am | | Reply

      mcityrk,
      the problem with individuals doing comparison tests is that they don’t have a standard to compare the results. every meter manufacturer, and the FDA, tells people not to compare one meter with another. if you used UniStrip1 test strips and OneTouch Ultra test strips with the same meter, how would you know which reading you should use to judge them? if one is 10% higher than the actual, and one is 10% lower than the actual, they are both well within the FDA standard—-but 20% different. all meters have tolerances, and some tend to be biased toward high or low deviations. without the industry machine (YSI) used by most labs, the individual won’t know which results are more accurate.

  4. Bennet
    Bennet April 18, 2014 at 8:43 am | | Reply

    Who is responsible if there is an issue?

    The company who makes the meter?
    The company who made the strip?
    The user, to prove it was a meter purchased before either Oct. 2012 or July 2010?

    FDA views these things as systems – meters strip and algorithms – to make it all work. Lowering cost is a good idea. With a generic medication patients can know who is responsible: the company who made it. I think that generic strips should have an agreement in place, as the FDA’s proposed guidance suggests (line 990 of the over the counter document.) Agreements should be mandatory. Without agreements, the strip folks will point at the meter and the meter guys at the strip.

    Until they both figure out nobody can prove when they bought their meter, they will both blame the patient. There is too much blame the patient in diabetes already, we don’t need to be inventing new ways of doing it.

    Generics, like branded systems, needs to come ALL THE WAY UP to new standards for accuracy, labeling, lot release and more.

    1. Andy
      Andy April 21, 2014 at 9:43 am | | Reply

      Bennet,
      UniStrip Technologies provides a full-service customer care center for its products, and is in compliance with all reporting requirements of the FDA.
      UniStrip Technologies, with reference to the current Draft Guidance, has asked LifeScan to enter into discussions on this matter, as strongly encouraged by the FDA.
      UniStrip Technologies will remain open to all opportunities to ensure patient safety, whether with the public or with other manufacturers.
      Andy at UniStrip

      1. Bennet
        Bennet April 21, 2014 at 10:20 am | | Reply

        Hey Andy

        Thanks for joining the conversation.

        My view and views like Your Diabetes, May Vary (- see how I did that?) is that agreements should be mandatory, just like post market inspections.

        I really worry about the cut off dates for meter production and how are users meant to know which meter is what vintage.

        Resolving those concern is certainly possible.

        An accurate tool, have value and an inaccurate one has none.

        1. Andy
          Andy April 21, 2014 at 11:22 am |

          UniStrip and OK Biotech are routinely monitoring the monitors…..Though the 510k indicates a date of October 2012 for UniStrip1 test strips, OK Biotech conducts routine testing of new strips with new meters and then updates the cutoff dates, which is reflected in the packaging/labeling, and is currently displayed clearly on the lable of UniStrip1 test strips as “before 2014″. This process was addressed with the FDA pre-clearance, and is being done by the manufacturer post-clearance, which also provides effective and continuing “post-market surveillance” of the product.

        2. Bennet
          Bennet April 28, 2014 at 7:34 am |

          Thanks again Andy

  5. Third Party Strips – Who is Accountable? – StripSafely

    [...] Update 4/17: Diabetes Mine‘s Mike H. has a full article with all kinds of interesting detail and  reader comments on generics. Have a look. http://www.diabetesmine.com/2014/04/here-come-generics-test-strips-etc.html [...]

  6. Mike Anderson
    Mike Anderson April 18, 2014 at 9:39 am | | Reply

    Thanks for the comprehensive article Mike!

    Yes, it is always a balancing act between lower cost and reliability of test strips. But I’m not buying a Happy Meal at McDonalds. When it comes to managing my health, I will choose reliability and accurate test strip results over inexpensive or less reliable strips. We need to push all manufacturers, generics and big brands, to meet the same quality standard.

    The pending FDA draft guidelines on accuracy are still open for public commentary until May 7, 2014. In those guidelines, the FDA has specific language addressing quality measures third-party strip makers and that’s something we, as a D-Community, should be supporting.

  7. Laurie Dyer
    Laurie Dyer April 18, 2014 at 4:04 pm | | Reply

    For the last year my daughter had been using the Relion prime test strips from Walmart. They are $9 for 50 strips and just as accurate as her One a touch Ultra. Even with insurance the a Relion strips were cheaper to buy over-the-counter. Why would anyone pay more? With a change in our insurance her strips are now 100% covered so we’re back to the fancy “schmancy” brand.

  8. Jen
    Jen April 19, 2014 at 9:33 pm | | Reply

    Urgh. Insurance companies are going to have fun with the generics. I’ve never had good luck with low cost meters and strips(some major brand names, too) – too many variables to contend with so they often don’t work well for me. It’s pathetic what the mail order companies that Medicare(or most insurance companies now) patients must contend with give – no name meters and strips with ridiculously crappy accuracy that only function in the accuracy guidelines on paper and cannot handle the variables.

  9. Here Come Generics — Test Strips and a Ne...

    [...] It almost seems that a new era of alternative test strips and other "basic" diabetes products has hit. It's a sign of the times, really, as big-name brands are hurting because of Medicare competitive bidding changes that are limiting access to pricier products in favor of more economical options — giving producers of generics a…  [...]

  10. Procrastinators Unite… Tomorrow! | theperfectd™

    [...] also a great article on this very topic and details about the companies offering generic strips at Diabetes Mine. A definite must [...]

  11. Diabetes News, Views & Announcements - 4/25/14 | War On Diabetes

    [...] lives are resting on the information. And, the fact is, the testing can be much more accurate. Read this article, too.  Having said all of that, cheaper is not a bad thing – especially if more testing is [...]

  12. Here Come Generics — Test Strips and a Ne...

    [...] “ It almost seems that a new era of alternative test strips and other "basic" diabetes products has hit. It's a sign of the times, really, as big-name brands are hurting because of Medicare competitive bidding changes that are limiting access to pricier products in favor of more economical options — giving producers of generics a…”  [...]

  13. Victor A. Walsh
    Victor A. Walsh May 24, 2014 at 2:38 pm | | Reply

    Under its Local Coverage Determination (LCD) Medicare’s Noridian Healthcare Solutions now limits coverage of glucose test strips for insulin-treated diabetics to 300 over every three months. This became effective as of April 2013.

    Coverage for additional test strips requires documentation by the treating provider or physician that shows that the beneficiary is testing at a higher frequency and that such testing is both ‘reasonable and necessary’ for the diagnosis or treatment. Documentation includes patient’s log books and physician’s notes. This must be done every six months; otherwise, the beneficiary pays out-of-pocket for additional test strips, which usually cost between $1.30-$1.50/strip.

    This is an ongoing concern for me because Noridian’s records, including medical reviews, are not available to me. Furthermore, an untold number of endocrinologists are unfamiliar with Noridian’s requirements for additional coverage.

    I am anxious to hear about the experiences of other insulin-dependent diabetics under Medicare regarding coverage of Durable Medical Equipment (DME).

  14. The Problem With Generic Test Strips

    [...] weird language from the FDA for a meter cleared last December.)  Indeed, Mike Hoskins recently did a great feature about the issue, which, given yesterday’s notice, has proved to be disturbingly [...]

  15. Georgie
    Georgie June 28, 2014 at 11:42 am | | Reply

    So now I’m very confused. People have been telling me the Unistrip 50 ct Test Strips for use with OneTouch Ultra Meters will not work in models that were made after 2012. Is this true or not? My dog was diagnosed June 12th and the Ultra One Touch2 is very accurate for her. I’m on a very limited budget and cannot afford the OneTouch strips. So I need this question definitively answered, once and for all.
    Georgie

  16. Mary
    Mary July 9, 2014 at 11:42 am | | Reply

    I just got a OneTouch Ultra and have only used manufacturer strips. Almost ALL tests have come in low. The strips to not accept the blood fast to get an accurate reading as far as I can tell.
    I did find test strips that will work with my Relion Ultima meter so do not plan to continue using the OneTouch at all.

  17. Eldon
    Eldon July 27, 2014 at 5:54 pm | | Reply

    Just found the site and thought I would give my limited personal experience with UniStrip1 Test Strips.
    Purchased a 50 pack and compared several to fresh One Touch strips by testing with one and immediately changing the coding [Unistrip uses code 49] pricking finger again and test. In every case they have been within 6 digits which surprised me, I have done this in the past with two One Touch strips and had larger variance.
    This is only one person and one vial but thought it worth sharing.

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