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SD Codefree meter- accurate or not

Discussion in 'Newly Diagnosed' started by Dexterdobe, Mar 3, 2018.

  1. Oldvatr

    Oldvatr Other · Well-Known Member

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    Acording to the info supplied with the test strips, purchased this year, then the accuracy is defined in accordance with ISO 15197:2013 and so is not certified to the required standard. The note in the leaflet says that this accuracy is only valid for a limited time, but does not state what this limit is. in terms of the manufacture date.

    The meter performance is only to an earlier version of this standard (2003) according to same leaflet, so the meter has not been recently re-qualified. The SD leaflet was last updated in 2014, so will not show any data to the required 2015 (or even 2016/17) standards.
     
  2. urbanracer

    urbanracer Type 1 · Moderator
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    @Oldvatr

    Standard ISO 15197:2013 is the latest and current version of the standard governing blood glucose test meters. The previous version was dated 2003.

    Medical device manufacturers are typically given 3 yrs to implement the standard - hence a cut off date of 2016.
     
  3. Oldvatr

    Oldvatr Other · Well-Known Member

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    ISO 2013 does not address the problems of haematocrit sensitivity, the EU harmonised standard (current standard 2015) does address the testing and ranges the meters have to meet. Also, since 2013 was published, the problems of Maltose sensitivity have been shown to affect accuracy, and 2015 standard also requires this test to be done and reported. At the time my CCG and others were evaluating meters for future use (GMMMB study) all meters and supplies should have been in place for the 2015 standard.

    http://www.standardscentre.co.uk/bs/BS-EN-ISO-15197-2015/
     
  4. urbanracer

    urbanracer Type 1 · Moderator
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    upload_2018-3-4_12-16-7.png

    There is also 3 year transition period to June 2018.
     
  5. Oldvatr

    Oldvatr Other · Well-Known Member

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    What is your source here? I have found it in the Irish adoption of the ISO 2015 standard, but I have not found any CEN statements to validate this claim. The document itself is behind a paywall

    The BSI equivalent document has several changes incorporated since the 2013 issue. This endorsemen of yours shows that the BSI has been ignored completely.

    According to CEN lex,europa.eu the cutoff date for compliance is 30.6.2017.
     
  6. Incyb

    Incyb Type 2 · Well-Known Member

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    I used the Accuchek proforma for a year, then bought the SD codefree a few weeks ago. I've been feeling confused and a bit miserable since because of inexplicably higher readings ... I conclude my SD gives higher readings than my Accuchek. I'm going to get strips for my old meter and do double tests for a week or two to confirm.
     
  7. Bluetit1802

    Bluetit1802 Type 2 (in remission!) · Guru

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    The Codefree is known to read a bit higher, but not enough to be significant if all you are looking for are trends. There is no harm in doing a few comparison tests. I have done many in my time, but once you can work out how much higher it reads ON AVERAGE put the old meter away for emergencies or you will be forever confused.
     
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  8. Oldvatr

    Oldvatr Other · Well-Known Member

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    I know this thread has gone sleepy byebyes, but here is an update from me. I use 2 meters in parallel testing at least 3 times a day (I know, OCD etc) and for the last 6 months my daily average between these meters are proving to be relatively constant (this the average per day over weeks or months even)
    My Caresense Dual meter has been giving me an average reading of 6,2 mmol.l, and my SD Codefree has averaged to 7.0 mmol.l over the same period, Just had the results of my latest HbA1c which was 42 (Yay I finally got there !) which the converter app on this site estimates is equivalent to an average home meter reading of 7.0 mmol/l (or 6%) and so it appears that my Codefree is spot on in terms of accuracy, and my Dual is reading about 0.8 mmol/l low, This is actually within the ISO requirements, so the Dual is also regarded as accurate.
     
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  9. shelley262

    shelley262 Type 2 · Well-Known Member

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    @Oldvatr th@nks for info useful. Also sounds like congratulations are in order for your hbaca1 well done - sending you a congratulatory pat on the back.
     
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  10. Bluetit1802

    Bluetit1802 Type 2 (in remission!) · Guru

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    Well done! That is wonderful news for you. :)
     
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  11. Alexandra100

    Alexandra100 Prefer not to say · Well-Known Member

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    Don't apologise! Every time I see a number I don't expect (or, if I'm honest, don't like) on my Codefree I retest on my TEE2. And depending on the result, sometimes go back to my Codefree for a third go. But if they both say about the same, I do have to accept that! I admit I cheat, in that a surprisingly high number leads to a retest, but a surprisingly low 4.8 / 4.9 doesn't. It would be too sad to see that good number and then lose it again.
     
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  12. xfieldok

    xfieldok Type 2 · Well-Known Member

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    Happy with my CodeFree. I use it with the Agamatrixjazz from the surgery. Only once have they matched but they are within a reasonable tolerance. I generally use the same blood drop for both meters. I find I can get different readings from different fingers. So I treat it as a general guide.
     
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  13. Oldvatr

    Oldvatr Other · Well-Known Member

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    Thank you all. I felt I needed to justify my stance on some matters and now I have the proof I wanted, I am not cured or reversed, merely in control, But it helps.

    Edit: Thank you BB. In my eyes you are a winner too even though we crossed swords recently in another thread..
     
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    #33 Oldvatr, Apr 11, 2018 at 11:19 PM
    Last edited: Apr 11, 2018
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