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FDA Issues Warning About Test Strips That Can Give False Readings, Lead to Insulin Overdoses

Aug 24, 2009

The FDA warning is based on 13 deaths between 1997 and 2009 that were reported in healthcare facilities where patients used the test strips. People with diabetes who are at highest risk are those undergoing dialysis or recovering from recent surgery.

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.]

Because the strips can mistake non-glucose sugars for glucose, they can give an inaccurately high BG reading that could lead to an insulin overdose.

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.

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."

List of GDH-PQQ Glucose Test Strips

The FDA noted that the following test strips and their associated meters use GDH-PQQ methodology as of August 2009.

Roche Diagnostics

  1. ACCU-CHEK Comfort Curve test strips, for use with:
    • ACCU-CHEK Inform meters [model 2001201]
    • ACCU-CHEK Complete meters [models 200 and 250]
    • ACCU-CHEK Advantage meters [models 888, 831, 850, and 768]
    • ACCU-CHEK Voicemate meters [model 0009221]
  2. ACCU-CHEK Aviva test strips, for use with:
    • ACCU-CHEK Aviva meters [models 525, 535, and 555]
  3. ACCU-CHEK Compact test strips, for use with:
    • ACCU-CHEK Compact meters [model GF]
    • ACCU-CHEK Compact Plus meters [models GP and GT]
  4. ACCU-CHEK Go test strips, for use with:
    • ACCU-CHEK Go meters [model GJ]
  5. ACCU-CHEK Active test strips, for use with:
    • ACCU-CHEK Active meters [models GG and GN]

Abbott Diabetes Care

  1. Freestyle test strips, for use with:
    • FreeStyle meters
    • FreeStyle Flash meters
    • FreeStyle Freedom meters
  2. Freestyle Lite test strips, for use with:
    • FreeStyle Lite meters
    • FreeStyle Freedom Lite meters

Home Diagnostics

  1. TRUEtest test strips, for use with:
    • TRUEresult meters
    • TRUE2go meters

Smiths Medical

  1. Abbott Diabetes Care Freestyle test strips, for use with:
    • CoZmonitor blood glucose module (for use with the Deltec Cozmo Insulin Pump)

Insulet

  1. Abbott Diabetes Care Freestyle test strips, for use with:
    • OmniPod Insulin Management System

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.

The FDA warning and the agency's patient advice are available online.

Manufacturer Responses

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 glucose meters."

Arkray 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."


Categories: Blood Glucose, Blood Sugar, Community, Diabetes, Diabetes, Food, Government & Policy, Health, Insulin, Insulin Pumps, Losing weight, Meters, Type 1 Issues, Type 2 Issues



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Comments

Posted by Anonymous on 1 September 2009

this is industry driven marketing hype, notice the very few patients in very scenarios it affects, and it will be over blown by media and the competitors

Posted by Anonymous on 1 September 2009

13 deaths in 12 years in patients with diabetes in nursing homes on dialysis or post op, and they are sure it is the test strips >??? please.....
how often do patients and or nurses blame abnormal blood sugars on the meter or strips ????

Posted by Anonymous on 2 September 2009

There is absolutely no need to remove home testing meters from Diabetes Education Centres situated in, or associated with, hospitals. The only glucose result allowed to be interpreted within these institutions are hospital/lab approved meters. DNE's know 100% whether their patients administer the drugs in question and whether these patients should take home one of the meters indicated. If the threat were serious the FDA would lift the license on all of the instruments mentioned.

Posted by Anonymous on 3 September 2009

No matter how small the sample size, this is good information. If it were your loved one whose BG went morbidly low, it would not be insignificant. Hopefully this will drive the industry to get more precise and lower range of error.

Posted by Anonymous on 3 September 2009

So who's behind the conspiracy?

Posted by Anonymous on 4 September 2009

Those meter companies who produce those test strip chemistries should be d/c. This is how the tobacco industry problem started...a few deaths then it got huge and the tobacco industry down played it. Folks when the FDA gets involved listen and take note.

Posted by Anonymous on 16 October 2009

can you tell me if the prodigy auto code meter uses this typre of test strip?

Posted by Anonymous on 5 February 2010

What are these IDIOTS above basing their comments on? I am a diabetic who is on dialysis and my recent readings have been in the region of 20+ since i went on dialysis. I have had a hypo every day over the last 2 weeks. I could have done with this information 2 weeks ago when I first went on dialysis!!!!

Posted by Anonymous on 1 April 2010

Our son uses 3 different meter types and we have found the Accu-check meter to give INNACURATE readings. They can be off 2-10 points regularily. This can be very dangerous - short term insulin overdose, long-term poor control. These need to be D/C'd IMMEDIATELY!!!

Posted by Anonymous on 9 April 2010

As a Medical Technologist for the past 18 years, I can assure you that it is possible for any type of testing methodology to be inaccurate due to interfering substances. If you are an inpatient with concerns, request a glucose test from the lab. Dialysis patients should always have blood drawn to be lab-checked.


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