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[IP] Potentially Fatal Glucose Monitoring Errors with Icodextrin

>From the FDA
Preventing Medical Errors

Potentially Fatal Glucose Monitoring Errors with Icodextrin

The Institute for Safe Medication Practices (ISMP) is warning again about
the possibility of potentially fatal glucose monitoring errors in patients
receiving products that contain other sugars. These include oral xylose,
parenterals that contain maltose or galactose, and peritoneal dialysis
solutions that contain icodextrin. This issue was also reported in an
earlier edition of FDA Patient Safety News.

The problem is that some point-of-care glucose meters use a type of test
strip that cannot distinguish between glucose and other sugars. So in these
cases, the meter's reading of the test strip will reflect both the patient's
actual blood glucose and the other sugar the patient has received. This
falsely elevated reading can lead to aggressive insulin treatment, which can
result in hypoglycemic shock and death.

The latest ISMP report concentrates on Extraneal, a peritoneal dialysis
solution containing icodextrin, which is metabolized in the body to maltose.
The ISMP report notes that FDA has received 18 reports of hypoglycemic
adverse events associated with Extraneal since it was first marketed in
2002. In three cases, the patient or a family member told the hospital staff
about the potential problem, but the staff still relied on erroneous
readings from portable monitors.

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.

Here is what ISMP recommends to prevent these glucose monitoring errors in
hospitals. Consider using only glucose meters that use test strips that can
distinguish between glucose and other sugars. If you use meters and strips
that cannot distinguish between the sugars, take these additional

 On admission and periodically during the hospital stay, find out whether
the patient is receiving medications containing other sugars. If so, monitor
glucose using only hospital laboratory methods.

 Periodically verify point-of-care blood glucose readings with laboratory
results. This can detect errors in glucose meter readings early enough to
prevent harm. This is especially important in patients who are unconscious
or unable to communicate, since it may be difficult to ascertain the
symptoms of hypoglycemia or the medication history.

 Educate the staff about this potentially fatal problem, and consider
safeguards such as drug interaction alerts in computer order entry systems,
patient profiles and charts.

Additional Information:

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.


Lifescan strips use Glucose oxidase, The safe strips.

John S Wilkinson
Rome, NY
"A hospital bed is a parked taxi with the meter running."
-- Groucho Marx
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