Take Very Good
Care of YouselvesDeuteronomy 4:15



BS'D


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class=MsoNormal>style="FONT-SIZE: 24pt; mso-ansi-language: EN; mso-font-kerning: 18.0pt"
lang=EN> About Test Strips That Can Give False
Readings, Lead
to Insulin Overdoses


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class=MsoNormal>face="Times New Roman">The U.S. Food and Drug Administration has issued a
warning against the use of GDH-PQQ blood glucose test strips by people with
diabetes who are taking medications that contain non-glucose sugars. [Note:
GDH-PQQ is the abbreviation of "glucose dehydrogenase pyrroloquinoline quinone,"
a chemical that reacts with the non-glucose sugars maltose, galactose, and
xylose, which are contained in some therapeutic
products.]


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class=MsoNormal>face="Times New Roman">Because the strips can mistake non-glucose sugars for
glucose, they can give an inaccurately high BG reading that could lead to an
href="http://www.diabeteshealth.com/ads/www/delivery/ck.php?oaparams=2__bannerid=324__zoneid=0__cb=43fec71ccb__maxdest=http://www.diabeteshealth.com/browse/medications/insulin/">size=3 face="Times New Roman">insulinface="Times New Roman"> overdose.


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class=MsoNormal>face="Times New Roman">The FDA warning is based on 13 deaths between 1997 and
2009 that were reported in healthcare facilities where patients were using the
test strips. People with diabetes who are at highest risk are those undergoing
dialysis or recovering from recent surgery.


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class=MsoNormal>face="Times New Roman">According to the FDA alert, "Non-glucose sugars contained
in some therapeutic products, such as peritoneal dialysis solutions and certain
immunoglobulins, can falsely elevate glucose results, which may prompt excessive
insulin administration. These therapeutic products, which are labeled to
indicate that they may interfere with this particular glucose monitoring
technology, are mostly used in patients with serious medical conditions,
including kidney failure and moderate to severe rheumatoid
arthritis."


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class=MsoNormal>style="FONT-SIZE: 10.5pt; mso-ansi-language: EN" lang=EN>face="Times New Roman">List of GDH-PQQ Glucose Test
Strips
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class=MsoNormal>face="Times New Roman">The FDA noted that the following test strips and their
associated meters use GDH-PQQ methodology as of August
2009.


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class=MsoNormal>size=3>Roche
Diagnostics



  1. style="TEXT-ALIGN: left; MARGIN: 0in 0in 0pt 0.5in; unicode-bidi: embed; DIRECTION: ltr; tab-stops: list .5in; mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-list: l2 level1 lfo1"
    class=MsoNormal>face="Times New Roman">ACCU-CHEK Comfort Curve test strips, for use with:


    • style="TEXT-ALIGN: left; MARGIN: 0in 0in 0pt 0.5in; unicode-bidi: embed; DIRECTION: ltr; tab-stops: list 1.0in; mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-list: l2 level2 lfo1"
      class=MsoNormal>face="Times New Roman">ACCU-CHEK Inform meters [model 2001201]

    • style="TEXT-ALIGN: left; MARGIN: 0in 0in 0pt 0.5in; unicode-bidi: embed; DIRECTION: ltr; tab-stops: list 1.0in; mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-list: l2 level2 lfo1"
      class=MsoNormal>face="Times New Roman">ACCU-CHEK Complete meters [models 200 and 250]

    • style="TEXT-ALIGN: left; MARGIN: 0in 0in 0pt 0.5in; unicode-bidi: embed; DIRECTION: ltr; tab-stops: list 1.0in; mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-list: l2 level2 lfo1"
      class=MsoNormal>face="Times New Roman">ACCU-CHEK Advantage meters [models 888, 831, 850, and
      768]

    • style="TEXT-ALIGN: left; MARGIN: 0in 0in 0pt 0.5in; unicode-bidi: embed; DIRECTION: ltr; tab-stops: list 1.0in; mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-list: l2 level2 lfo1"
      class=MsoNormal>face="Times New Roman">ACCU-CHEK Voicemate meters [model 0009221]

  2. style="TEXT-ALIGN: left; MARGIN: 0in 0in 0pt 0.5in; unicode-bidi: embed; DIRECTION: ltr; tab-stops: list .5in; mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-list: l2 level1 lfo1"
    class=MsoNormal>face="Times New Roman">ACCU-CHEK Aviva test strips, for use with:


    • style="TEXT-ALIGN: left; MARGIN: 0in 0in 0pt 0.5in; unicode-bidi: embed; DIRECTION: ltr; tab-stops: list 1.0in; mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-list: l2 level2 lfo1"
      class=MsoNormal>face="Times New Roman">ACCU-CHEK Aviva meters [models 525, 535, and 555]

  3. style="TEXT-ALIGN: left; MARGIN: 0in 0in 0pt 0.5in; unicode-bidi: embed; DIRECTION: ltr; tab-stops: list .5in; mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-list: l2 level1 lfo1"
    class=MsoNormal>face="Times New Roman">ACCU-CHEK Compact test strips, for use with:


    • style="TEXT-ALIGN: left; MARGIN: 0in 0in 0pt 0.5in; unicode-bidi: embed; DIRECTION: ltr; tab-stops: list 1.0in; mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-list: l2 level2 lfo1"
      class=MsoNormal>face="Times New Roman">ACCU-CHEK Compact meters [model GF]

    • style="TEXT-ALIGN: left; MARGIN: 0in 0in 0pt 0.5in; unicode-bidi: embed; DIRECTION: ltr; tab-stops: list 1.0in; mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-list: l2 level2 lfo1"
      class=MsoNormal>face="Times New Roman">ACCU-CHEK Compact Plus meters [models GP and GT]

  4. style="TEXT-ALIGN: left; MARGIN: 0in 0in 0pt 0.5in; unicode-bidi: embed; DIRECTION: ltr; tab-stops: list .5in; mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-list: l2 level1 lfo1"
    class=MsoNormal>face="Times New Roman">ACCU-CHEK Go test strips, for use with:


    • style="TEXT-ALIGN: left; MARGIN: 0in 0in 0pt 0.5in; unicode-bidi: embed; DIRECTION: ltr; tab-stops: list 1.0in; mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-list: l2 level2 lfo1"
      class=MsoNormal>face="Times New Roman">ACCU-CHEK Go meters [model GJ]

  5. style="TEXT-ALIGN: left; MARGIN: 0in 0in 0pt 0.5in; unicode-bidi: embed; DIRECTION: ltr; tab-stops: list .5in; mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-list: l2 level1 lfo1"
    class=MsoNormal>face="Times New Roman">ACCU-CHEK Active test strips, for use with:


    • style="TEXT-ALIGN: left; MARGIN: 0in 0in 0pt 0.5in; unicode-bidi: embed; DIRECTION: ltr; tab-stops: list 1.0in; mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-list: l2 level2 lfo1"
      class=MsoNormal>face="Times New Roman">ACCU-CHEK Active meters [models GG and GN]

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class=MsoNormal>size=3>Abbott Diabetes
Care



  1. style="TEXT-ALIGN: left; MARGIN: 0in 0in 0pt 0.5in; unicode-bidi: embed; DIRECTION: ltr; tab-stops: list .5in; mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-list: l0 level1 lfo2"
    class=MsoNormal>face="Times New Roman">Freestyle test strips, for use with:


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      class=MsoNormal>face="Times New Roman">FreeStyle meters
    • style="TEXT-ALIGN: left; MARGIN: 0in 0in 0pt 0.5in; unicode-bidi: embed; DIRECTION: ltr; tab-stops: list 1.0in; mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-list: l0 level2 lfo2"
      class=MsoNormal>face="Times New Roman">FreeStyle Flash meters
    • style="TEXT-ALIGN: left; MARGIN: 0in 0in 0pt 0.5in; unicode-bidi: embed; DIRECTION: ltr; tab-stops: list 1.0in; mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-list: l0 level2 lfo2"
      class=MsoNormal>face="Times New Roman">FreeStyle Freedom meters

  2. style="TEXT-ALIGN: left; MARGIN: 0in 0in 0pt 0.5in; unicode-bidi: embed; DIRECTION: ltr; tab-stops: list .5in; mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-list: l0 level1 lfo2"
    class=MsoNormal>face="Times New Roman">Freestyle Lite test strips, for use with:


    • style="TEXT-ALIGN: left; MARGIN: 0in 0in 0pt 0.5in; unicode-bidi: embed; DIRECTION: ltr; tab-stops: list 1.0in; mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-list: l0 level2 lfo2"
      class=MsoNormal>face="Times New Roman">FreeStyle Lite meters
    • style="TEXT-ALIGN: left; MARGIN: 0in 0in 0pt 0.5in; unicode-bidi: embed; DIRECTION: ltr; tab-stops: list 1.0in; mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-list: l0 level2 lfo2"
      class=MsoNormal>face="Times New Roman">FreeStyle Freedom Lite meters

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class=MsoNormal>size=3>Home
Diagnostics



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    class=MsoNormal>face="Times New Roman">TRUEtest test strips, for use with:


    • style="TEXT-ALIGN: left; MARGIN: 0in 0in 0pt 0.5in; unicode-bidi: embed; DIRECTION: ltr; tab-stops: list 1.0in; mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-list: l3 level2 lfo3"
      class=MsoNormal>face="Times New Roman">TRUEresult meters
    • style="TEXT-ALIGN: left; MARGIN: 0in 0in 0pt 0.5in; unicode-bidi: embed; DIRECTION: ltr; tab-stops: list 1.0in; mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-list: l3 level2 lfo3"
      class=MsoNormal>face="Times New Roman">TRUE2go meters

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class=MsoNormal>size=3>Smiths
Medical



  1. style="TEXT-ALIGN: left; MARGIN: 0in 0in 0pt 0.5in; unicode-bidi: embed; DIRECTION: ltr; tab-stops: list .5in; mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-list: l1 level1 lfo4"
    class=MsoNormal>face="Times New Roman">Abbott Diabetes Care Freestyle test strips, for use with:


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class=MsoNormal>size=3>face="Times New Roman">Insulet



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    class=MsoNormal>face="Times New Roman">Abbott Diabetes Care Freestyle test strips, for use with:


    • style="TEXT-ALIGN: left; MARGIN: 0in 0in 0pt 0.5in; unicode-bidi: embed; DIRECTION: ltr; tab-stops: list 1.0in; mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-list: l4 level2 lfo5"
      class=MsoNormal>face="Times New Roman">OmniPod Insulin Management System

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class=MsoNormal>style="mso-ansi-language: EN" lang=EN>The FDA notes that test strips may be
distributed under multiple trade names. Because manufacturers of GDH-PQQ test
strips currently on the market may subsequently change to non-GDH-PQQ
methodology, the FDA recommends that healthcare providers and patients refer to
the labeling on their test devices or consult with test strip manufacturers to
confirm the type of BG measuring methodology they use.
style="mso-ansi-language: EN" lang=EN>


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class=MsoNormal>face="Times New Roman">The href="http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm176992.htm">size=3 face="Times New Roman">FDA warningface="Times New Roman"> and the agency's href="http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PatientAlerts/ucm177189.htm">size=3 face="Times New Roman">patient adviceface="Times New Roman"> are available
online.


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class=MsoNormal>style="mso-ansi-language: EN" lang=EN>Manufacturer Responsesstyle="mso-ansi-language: EN" lang=EN>


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class=MsoNormal>face="Times New Roman">Glucose test strip manufacturers have begun to respond to
the FDA warning. Bayer Diabetes Care said, "Since 2006, Bayer Diabetes
Care has not distributed test strips that use GDH-PQQ (glucose dehydrogenase
pyrroloquinoline quinone) glucose monitoring technology for its blood
href="http://www.diabeteshealth.com/ads/www/delivery/ck.php?oaparams=2__bannerid=286__zoneid=0__cb=331c9a7bd0__maxdest=http://diabeteshealth.com/browse/products/meters/">size=3 face="Times New Roman">glucose metersface="Times New Roman">."


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class=MsoNormal>style="mso-ansi-language: EN" lang=EN>Arkraystyle="mso-ansi-language: EN" lang=EN> stated "The GLUCOCARD 01 and Assure
families of products use a glucose-specific enzyme and can, therefore,
distinguish between glucose and other sugars. In light of the FDA's
announcement, ARKRAY will upgrade any consumer concerned about their GDH system
to a product from the GLUCOCARD 01 family at no
charge."


 





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