The Institute for Safe Medication Practices (ISMP) is warning diabetic patients about potentially fatal glucose monitoring errors in patients receiving products that contain other sugars. These include parenterals that contain maltose or galactose, oral xylose, and peritoneal dialysis solutions that contain icodextrin.
Some glucose meters use test strips that do not distinguish between glucose and the other sugars found in products mention above. In such cases, the reading may show blood sugar levels that include both the patients’ actual blood glucose levels as well as the other types of sugars that the diabetic patient has received.
A falsely elevated blood glucose reading could cause over-use of insulin by the patient, which could result in hypoglycemic shock and even death.
The FDA has received dozens of reports of hypoglycemic events associated with peritoneal dialysis solutions containing icodextrin, such as Extraneal. In one of the reported cases, a 62 year-old hospitalized dialysis patient on Extraneal therapy died from severe hypoglycemia because his treatment was based on falsely elevated glucose readings from an inappropriate meter. This occurred despite glucose readings from the hospital lab that were strikingly lower than those produced by the meter.
Test strips that cannot distinguish between glucose and other sugars contain reagents called GDH-PQQ or GDO. Other types of meters use reagents that are capable of distinguishing glucose from the other sugars. These reagents are called GDH-NAD, GDH-FAD, glucose oxidase and glucose hexokinase. It is important to check the package insert that comes with the test strips to determine which type of reagent they contain.
Patients should consider using only glucose meters that use test strips with the ability to distinguish between glucose and other sugars.
NOTE: This is just a warning. It is not a recall.
ISMP Medication Safety Alert! FDA Advise-ERR: Prevent dangerous drug-device interaction causing falsely elevated glucose levels. June 19, 2008.
FDA Drug Safety Newsletter. Icodextrin (marketed as EXTRANEAL) and Point-of-Care Glucose Monitoring. Volume 1, Number 4. Summer 2008.
FDA Center for Biologics Evaluation and Research. Fatal Iatrogenic Hypoglycemia: Falsely Elevated Blood Glucose Readings with a Point-of-Care Meter Due to a Maltose-Containing Intravenous Immune Globulin Product. April 17, 2008.
FDA MedWatch Safety Alert – Parenteral Maltose/Parenteral Galactose/Oral Xylose-Containing Products. 2005.
Richard L. Davis says
I am wondering where there is a list of the machines or strips so can find out which ones are recalled?
E. Sizemore says
Richard, this is just a warning. It is not a recall. You can check the package insert that comes with the test strips to determine which type of reagent they contain.
J. Lantz says
Both Abbott (Freestyle) and Roche (Accu-Check) use this particualr test strip chemistry. Only Bayer (Breeze 2 and Contour) and Lifescan (OneTouch) use the safer chemistry. Also, the Bayer meters don’t require any coding/calibration!
J. Lantz – you have not done your home work – what do you mean by safer chemistry in regards to the Bayer and Lifescan meters. All glucose strips have interferences! Roche products have been put through tests that have eliminated 125 potential interferences during development. This is about 5 times above and beyond on interference testing verses other glucose monitoring systems. Interferences that exist with other blood glucose monitoring systems (like Bayer and Lifescan) acetaminophen, oxygen and ascorbic acid – which have been eliminitated in Roche products.
So, what is safe? Don’t be so quick to say that one is safer than another. Also, no coding does not mean safer or accurate it is a convieniance. Keep in mind that only .1% of the diabetes population is affected and those individuals are on specific dialysis that is in hospital settings.
Your either a Bayer rep or do not research your topic at all. I am a life long diabetes patient and I study my products and know what treatments are out there.
G. Wright says
T…..You are incorrrect and have certainly NOT done your homework. The Bayer Contour meter is NOT AFFECTED by oxygen. It may, however, be affected by Xylose, which would only occur during a Xylose tolerance test. As far as accuracy without being coded, both Bayer products are extremely accurate and neither need to be coded. Why add the risk of forgetting to code when there is no need? Additionally, while true, only a small % of people may be affected by maltose interference, specific to dialysis, many more have the potential to be affected by galactose, which is a monosaccharide found in a vartiety of things such as dairy products as well as certain gums used in the sweetening process for thousands of things. I am not a rep for Bayer, nor a diabetic. I just know how to research a topic. “The More You Know….”
tony k. says
I just want to know the side effects listed by the FDA about the glucose meter using Glucose Oxydase strips like Glucoplus meters
jim snell says
I am tired of the dead ass FDA sitting on its hands over this issue and excusing the industry peddling this useless technology.
My body routinely shoots the trick sugars around the body loop for extra loops in body and liver to get rid of the trick sugars and in mean time these meters are readining 40 to 100 points off.
Bugger the FDA and its pussy willow response as wellas the rip off prices.
Enough is enough.