FDA Wants Facilities To Avoid Using GDH-PQQ Glucose Test Strips

Cheryl A. Thompson

BETHESDA, MD 14 August 2009—A potentially fatal drug–device interaction that FDA first called attention to in 2005 has been associated with the deaths of six patients since 2008, the agency announced Thursday.

All of the deaths occurred in health care facilities.

As a result, FDA now recommends that health care facilities avoid using glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) glucose test strips altogether.

The agency said that as of August 2009, the following test strips use the GDH-PQQ method, which does not differentiate among glucose, maltose, galactose, and xylose:

• ACCU-CHEK Comfort Curve test strips, by Roche Diagnostics, for use with ACCU-CHEK Inform meter model 2001201, ACCU-CHEK Complete meter models 200 and 250, ACCU-CHEK Advantage meter models 888, 831, 850, and 768, and ACCU-CHEK Voicemate meter model 0009221,
• ACCU-CHEK Aviva test strips, by Roche Diagnostics, for use with ACCU-CHEK Aviva meter models 525, 535, and 555,
• ACCU-CHEK Compact test strips, by Roche Diagnostics, for use with ACCU-CHEK Compact meter model GF and ACCU-CHEK Compact Plus meter models GP and GT,
• ACCU-CHEK Go test strips, by Roche Diagnostics, for use with ACCU-CHEK Go meter model GJ,
• ACCU-CHEK Active test strips, by Roche Diagnostics, for use with ACCU-CHEK Active meter models GG and GN,
• Freestyle test strips, by Abbott Diabetes Care, for use with FreeStyle, FreeStyle Flash, and FreeStyle Freedom meters,
• Freestyle Lite test strips, by Abbott Diabetes Care, for use with FreeStyle Lite and FreeStyle Freedom Lite meters,
• TRUEtest test strips, by Home Diagnostics, for use with TRUEresult and TRUE2go meters,
• Abbott Diabetes Care Freestyle test strips, by Smiths Medical, for use with the CoZmonitor blood glucose module, which attaches to the Deltec Cozmo insulin pump, and
• Abbott Diabetes Care Freestyle test strips, by Insulet, for use with the OmniPod Insulin Management System.

Despite providing the above list, FDA advised health care providers and patients to read the product's labeling or contact the manufacturer to confirm the glucose-test method. Test strips may be distributed under brand names in addition to those listed above. Also, any of the above manufacturers may change its test strips to a method other than GDH-PQQ but retain the brand name.

A test strip that cannot distinguish glucose from maltose, galactose, and xylose may produce an elevated glucose result if the blood sample came from a patient receiving certain drug or biological products, FDA explained.

All of the deaths associated with GDH-PQQ glucose test strips, FDA said, occurred after the patients received insulin doses or infusions that were guided by falsely elevated test results.

The agency advised those health care facilities that choose to use GDH-PQQ glucose test strips never to use them for patients receiving abatacept, hepatitis B immune globulin by Cangene, icodextrin peritoneal dialysis solution, icodextrin adhesion reduction solution, 5% intravenous immune globulin by Octapharma, iodine 1131 tositumomab, Rho(D) immune globulin by Cangene, tositumomab, vaccinia immune globulin, or any product containing or metabolized into maltose, galactose, or xylose. Also, do not use those test strips for patients who are unresponsive or cannot adequately communicate information about their medications.

The aforementioned patients, FDA said, should have their blood glucose concentration determined only with a laboratory-based assay.

FDA also suggested that health care facilities consider inserting drug-interaction alerts in computerized-order-entry systems, medication profiles, and patient charts to alert staff members to the potential for falsely elevated glucose results.