Glucose Meter Problems Reported to FDA

  size=3D4> face=3Dverdana,arial color=3D#c00000 size=3D5>Glucose Meter Problems =
Reported to=20
FDA

color=3D#000000=20
size=3D2>Reports from BG monitor users to FDA reveal the most common =
problems with=20
blood glucose monitors.

color=3D#000000=20
size=3D2>Glucose meters have unquestionable clinical utility, =
particularly in=20
management of diabetes mellitus. U.S. Food and Drug Administration (FDA) =

surveillance activities include monitoring adverse event reports from =
healthcare=20
professionals, manufacturers, and lay users.

color=3D#000000=20
size=3D2>To gain insight into problems reported to FDA on glucose =
meters, the FDA=20
analyzed reports received over a 3-year period (2000=962002) from all =
sources=20
(mandatory and voluntary) and focused on reports from =
users.

color=3D#000000=20
size=3D2>The results showed that the vast majority of in vitro =
diagnostic device=20
(IVD) reports (84%, n =3D 18,959) were on glucose meters, with 333 =
glucose meter=20
reports from users. Among the user reports, the most common problems =
were false=20
high or low values and erratic values. Unique issues reported included =
purchase=20
of incorrect glucose meter strips, calibration problems, and =
misunderstanding=20
how FDA regulates glucose device performance.

color=3D#000000=20
size=3D2>THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) receives more =
adverse event=20
reports on glucose meters than on any other in vitro diagnostic device =
(IVD).=20
They studied adverse event reports on glucose meters received during the =
3-year=20
period from 2000 through 2002, giving special attention to voluntary =
reports=20
submitted by device users through FDA's Med.-Watch program (see =
description=20
below). Most adverse event reports come to FDA from manufacturers as =
mandatory=20
reports. FDA requires manufacturers to investigate device problems, to =
take any=20
needed corrective actions, and to report their actions and conclusions =
to FDA.=20
FDA analyses often focus on mandatory reports because they include the =
results=20
of manufacturer investigations.

color=3D#000000=20
size=3D2>Given that approximately 4.2 million self-monitoring glucose =
test strips=20
are used each day in the United States, users reported very few problems =

directly to FDA.

color=3D#000000=20
size=3D2>Most (53%) of the voluntary reports on glucose meters came from =
patients.=20
By comparison, only 17% of reports on all IVD products came from =
patients.=20
Others who submitted re-ports on glucose meters included patient family =
members,=20
pharmacists, other healthcare providers, and (in one case) an=20
attorney.

color=3D#000000=20
size=3D2>Among the voluntary reports, the most commonly reported glucose =
meter=20
problems were false high values (n =3D 17), false low values (n =3D 15), =
and erratic=20
values (n =3D 11). In addition, reports identified a number of unique =
issues:=20

color=3D#000000=20
size=3D2>*Six users reported they had inadvertently purchased meter =
strips labeled=20
not for use in the United States. These strips often exhibited =
differences in=20
calibration, labeling, and expiration dating. Users should be advised to =
check=20
their glucose strip labeling and promptly return any inappropriately =
imported=20
strips.

color=3D#000000 size=3D2>=95=20
Two users did not know the two ways to calibrate glucose meters to =
measure=20
finger stick glucose are to match finger stick glucose results with: (1) =
glucose=20
results in whole blood and (2) glucose results in plasma. Both ways =
produce=20
clinically valuable results; however, the results differ in that plasma =
results=20
are 10=9612% higher than whole blood results. Users should carefully =
read all=20
labels and instructions for use for their meter and their glucose test =
strips to=20
determine how their meter is calibrated, and to understand how =
calibration=20
affects their treatment decisions.

color=3D#000000 size=3D2>=95=20
Some users expressed surprise that FDA does not have performance =
requirements=20
for glucose meters. The Medical Device Amendments of 1976 require new =
tests to=20
be as accurate as old tests. The Diabetes Control and Complications =
Trial=20
unequivocally indicated home glucose measurements are=20
valuable.

color=3D#000000 size=3D2>*=20
Data suggest the current generation of glucose meters performs better =
than those=20
used in that study. An absolute measure of accuracy for glucose has not =
been=20
defined. Because no universally recognized glucose reference method =
exists, it=20
is difficult to compare the performance of glucose meters. =

color=3D#000000=20
size=3D2>Recently, FDA worked with scientists across the globe to =
develop a new=20
standard for glucose meters that sets a target of 20% total error and =
requires=20
labeling to help communicate meter performance.

color=3D#000000 size=3D2>=95=20
Some reports indicated users did not know how to check glucose meter=20
performance. Users should know they can compare their meter results with =
the=20
result of a laboratory test ordered by their =
physician.

color=3D#000000=20
size=3D2>Additionally, users should know that manufacturers of glucose =
meters will=20
provide them:

color=3D#000000 size=3D2>=95=20
technical support
=95 quality control materials they can use to check =
or=20
monitor meter performance
=95 replacement strips, meters, and =
calibration check=20
materials

color=3D#000000=20
size=3D2>MedWatch is the FDA Safety Information and Adverse Event =
Reporting=20
Program, is FDA's established mechanism for healthcare professionals and =
others=20
to voluntarily report problems suspected to be associated with drugs and =
medical=20
devices they prescribe, dispense, or use. MedWatch also provides =
information=20
about safety issues involving medical products, including prescription =
and=20
over-the-counter drugs, biologics, medical and radiation-emitting =
devices, and=20
special nutritional products. Medical product safety alerts, recalls,=20
withdrawals, and important labeling changes are disseminated to the =
medical=20
community and the general public on the MedWatch web site at:=20
http://w-vvw.fda.gov/medwatch/index.htiid.
FDA encourages those who =
use=20
glucose meters to report problems to MedWatch. Reports can be submitted =
as=20
follows:

color=3D#000000=20
size=3D2>Fax to 1-800-FDA-0178, Phone to 1-800-FDA-1088, submit online =
at:=20
www.fda.gov/medwatch or mail to MedWatch, FDA, HF-2, 5600 Fishers Lane,=20
Rockville, MD 20852-9787

color=3D#000000=20
size=3D2>REFERENCES
1. The U.S. blood glucose strips =
market:=20
diabetes glucose self-monitoring test strips market: annual utilization =
of test=20
strips 2002. Dialog File Number 767. Accession Number 1022839. London: =
Frost and=20
Sullivan. Available from: http://www.dialogselect.com/business/ =
cgi/present.=20
Accessed 09 June 2003.
2. Weitgasser R, Gappmayer B, Pichler M: Newer =

portable glucose meters=97analytical improvement compared with previous =
generation=20
devices? Clin Chem 1999;45:1821-1825.
3. International =
Standardization=20
Organization: ISO/FDIS 15197:2003(E). Requirements for In Vitro Blood =
Glucose=20
Monitoring Systems for Self-Testing in Managing Diabetes Mellitus. U.S.=20
Technical Advisory Group for ISO/TC212. Administered by NCCLS. Wayne, =
PA: Global=20
Consensus
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