FDA Warns GDH-PQQ Glucose Test Strips May Lead to Serious Injury or Death

The FDA is warning diabetics to avoid using glucose test strips or meters relying on glucose dehydrogenase pyrroloquinoline quinone (GHD-PQQ) because the strips can give false readings that could lead the user to mistakenly take an insulin overdose.

The warning, issued August 13, alerts users that GDH-PQQ-based glucose test strips or meters cannot distinguish between glucose and non-glucose sugars, which may be an ingredient in other medications. This can lead to false blood sugar readings and mask significant hypoglycemia or result in the user taking too much insulin, leading to an overdose and possibly death.

At least 13 deaths since 1997, six of which occurred in the last two years, have been attributed to the GHD-PPQ glucose test strip problems, according to the FDA.

The FDA released a list of test strips using the GDH-PQQ methodology that diabetics and healthcare professionals should avoid. The entire list, available on the FDA website, includes certain types of ACCU-CHEK test strips by Roche Diagnostics, Freestyle test strips by Abbott Diabetes Care, and TRUEtest test strips by Home Diagnostics. The FDA says it is working with the manufacturers to address the problems with the GDH-PQQ strips.

The GDH-PQQ glucose test strips can generate results three to 15 times higher than normal when the patient is on other medications using maltose or other non-glucose sugars. Three of the 13 patients who died as a result of insulin overdose were receiving maltose-containing medications, while ten others were receiving Extraneal (icodextrin) peritoneal dialysis solution for renal failure.

All of the glucose test strip deaths occurred when the patients were given an overdose of insulin guided by the false readings. The FDA reports that, for example, the test strips reported a blood glucose level of 193 mg/dL for a patient later found by laboratory tests to only have a blood level of 8 mg/dL. In some cases, patients suffered serious injury before death, including hypoglycemia, confusion, neurologic deterioration, severe hypoxia, brain damage and coma.

The FDA warned that the test strips listed may be distributed under multiple names, and manufacturers may change to non-GFH-PQQ methodology but keep the same names, so patients and healthcare providers should always check device labeling or contact the test strip manufacturer to confirm the type of methodology used.

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
   • ACCU-CHEK Go meters [model GJ]
5. ACCU-CHEK Active test strips
   • 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
   • 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