The FDA says:

This is to alert you to the possibility of falsely elevated blood glucose results when using GDH-PQQ glucose test strips on patients who are receiving therapeutic products containing certain non-glucose sugars. These sugars can falsely elevate glucose results, which may mask significant hypoglycemia or prompt excessive insulin administration, leading to serious injury or death. The following provides background information on this problem, a summary of fatality reports FDA has received, and recommendations to reduce the risk. This problem can occur wherever these products are used including in-patient and out-patient healthcare facilities, and at home.

This seems to be a recurring topic, here’s a FDA warning video from 2008:

Find full details here: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm176992.htm

Here is a full list of to known affected Meters/Strips:

List of GDH-PQQ Glucose Test Strips
The following test strips (with associated meters) use GDH-PQQ methodology as of August 2009:
Roche Diagnostics:

• 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]


• ACCU-CHEK Aviva test strips, for use with:


• ACCU-CHEK Aviva meters [models 525, 535, and 555]


• ACCU-CHEK Compact test strips, for use with:


• ACCU-CHEK Compact meters [model GF]


• ACCU-CHEK Compact Plus meters [models GP and GT]


• ACCU-CHEK Go test strips


• ACCU-CHEK Go meters [model GJ]


• ACCU-CHEK Active test strips


• ACCU-CHEK Active meters [models GG and GN]

Abbott Diabetes Care:

• Freestyle test strips, for use with:


• FreeStyle meters


• FreeStyle Flash meters


• FreeStyle Freedom meters


• Freestyle Lite test strips, for use with:


• FreeStyle Lite meters


• FreeStyle Freedom Lite meters

Home Diagnostics:

TRUEtest test strips
TRUEresult meters
TRUE2go meters

Smiths Medical:

Abbott Diabetes Care Freestyle test strips, for use with:
CoZmonitor blood glucose module (for use with the Deltec Cozmo Insulin Pump)
Insulet:
Abbott Diabetes Care Freestyle test strips, for use with:
OmniPod Insulin Management System

This entry was posted on Friday, August 14th, 2009 at 4:04 am and is filed under CGMS/Insulin Pumps, Diabetes Medication, Diabetes News, Diabetes Tech, Glucose Management, SugarStats Status.
Tags: Alert, FDA, GDH-PQQ, Glucose Meter, Test Strips.
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