Pharmaceutical

FDA sends warning about glucose test strips

The Food and Drug Administration (FDA) is issuing a warning to diabetes health care professionals, hospital risk managers and patients about a brand of glucose test strips that may falsely report elevated blood glucose results, which may mask significant hypoglycemia or prompt excessive insulin administration, leading to serious injury or death.

GDH-PQQ glucose monitoring measures a patient’s blood glucose value using methodology that cannot distinguish between glucose and other sugars. Certain non-glucose sugars, including maltose, xylose and galactose, are found in certain drug and biologic formulas, or can result from the metabolism of a drug or therapeutic product.

The FDA Public Health Notification includes the following GDH-PQQ Glucose Test Strips, also in use with associated meters:

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

Test strips currently on the market may be distributed under multiple trade names. In addition, manufacturers of GDH-PQQ test strips currently on the market may subsequently change to non-GDH-PQQ methodology. Therefore, health care providers (and patients) should refer to device labeling or consult with test strip manufacturers to confirm the type of methodology used.

The FDA recommends that healthcare practitioners avoid using GDH-PQQ glucose test strips in healthcare facilities or take steps to never use them on patients receiving interfering substances.