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FDA Issues Another Safety Alert Over Glucose Monitors

Posted by Jane Akre
Thursday, October 08, 2009 12:02 PM EST
Category: Major Medical
Tags: FDA, Glucose Test Strips, Diabetes, Blood Sugar, Glucose Monitors, FDA Safety Warning

FDA: Second Warning



The FDA is again warning the public about potentially fatal glucose monitoring errors with certain test strips, the GDH-PQQ. This applies to any patient who is receiving therapeutic products containing sugars other than glucose. That can include oral xylose, IV infusions containing maltose or galactose and peritoneal dialysis solutions with icodextrin, such as Extraneal.

The problem with the test strips is that some cannot distinguish between glucose and other sugars. Using them to read blood sugar can actually reflect elevated readings from the other sugars the patient received. “These falsely elevated readings can mask significant hypoglycemia, or they can lead to excessive insulin administration” says the agency.

That has resulted in death for 13 patients, as well as severe hypoglycemia or coma. All of the deaths occurred in healthcare facilities and 10 of the 13 patients were receiving Extraneal peritoneal dialysis solution for renal failure.

The FDA is recommending that health care facilities do not use the GDH-PQQ glucose test strips which are found in ACCU-CHEK, TRUEtest and Freestyle test strips. If a patient is receiving products that contain sugars other than glucose should be identified and monitored.

This is the second warning, after a similar one was issued in August. Six of the 13 deaths have occurred since 2008, despite previous warnings from the FDA. People at highest risk are those undergoing dialysis or recovering from a recent surgery, reports Diabetes Health.

List of GDH-OQQ 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)


  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.

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