Of Special Interest to Laboratorians/LabNet
MedSun: Newsletter #21, February 2008

Reporting Problems with Glucose Meters and Continuous Glucose Monitoring Systems

Please visit http://www.fda.gov/cdrh/oivd/reportingglucose.html for information to provide you with a least burdensome way of reporting the problems you may encounter when using your Glucose Meter or Continuous Glucose Monitoring System (CGMS).
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Glucose Meter Test Results: Useful Tips to Increase Accuracy and Reduce Errors

Have you ever wondered why you got a bad glucose meter test result when there is nothing obvious wrong with your meter, your test strips are new, and you’ve been running glucose tests for years? The simple answer is that glucose meters are not perfect, and neither are the people who use them!

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Draft Guidance for Industry and FDA Staff - Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems
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LabNet Focus Call on User Experience with Glucose Meters in Healthcare Settings
By: Mingdong Zhang, M.D., M.P.H., Ph.D., OSB and OIVD, CDRH, FDA

With approximately 20 million individuals diagnosed with diabetes in the U.S. and the number increasing rapidly, FDA is very interested in learning more about user experience with glucose meters. Diabetes care has become a significant public health burden. Accurate measurement of blood glucose with glucose meters is important in the management of diabetes to reduce complications. Erroneous readings of blood glucose levels could lead to serious clinical consequences. Each year, CDRH/FDA receives more than 10,000 medical device reports (MDRs) on blood glucose meters. These reports capture serious adverse events including malfunction, injury and death. The majority of the reports cite inaccurate readings as the problem. FDA is currently working to determine major causes for and identify solutions for inaccurate readings of glucose meters. Given the significance of diabetes care in the U.S., any improvement in the accuracy of glucose monitoring would have a great public health impact.

On October 9, 2007, CDRH conducted a focus call on user experience with glucose meters in health care settings with nine LabNet hospitals.

The purpose of the discussion was for the FDA to gain better understanding of user experience with glucose meters in point-of-care settings. The discussion focused on usage of the meters on clinical units, important criteria for selecting meters, common problems with glucose meters, medical problems that might be caused by glucose meters, and training of personnel using glucose meters.

The following points were made by the LabNet facility participants during the focus call:
•Glucose meters are used in both outpatient and inpatient units. Most facilities use one type of meter on all clinical units.
•Accuracy and precision are the most important criteria in glucose meter purchasing decisions.
•Some of the common problems with glucose meters are use errors and measurement inaccuracies. Concerns were expressed about different readings by different meters on the same sample (the difference can be as high as 100 points).
•Of particular interest to FDA was the discussion about the kind of patient conditions that might significantly affect glucose meter readings. Many facilities reported instances in the hospital where inaccurately high blood glucose meter readings were obtained on patients who were very ill. These patients were given insulin and subsequently became hypoglycemic. The conditions of concern included: very high or very low hematocrit, excess uric acid levels, certain medications, vasopressors, septicemia, physiological conditions such as heart failure, an ejection fraction less than 20%, pitting edema, severe dehydration, hypotension, and peripheral vascular disease.
•Tests are usually repeated or laboratory confirmations are requested when results are in doubt. Some facilities implemented internal guidelines for repeating tests, e.g., a test is repeated when a critically high (over 400mg/dL inpatient or over 300 mg/dL outpatient) or a critically low (below 50 mg/dL) test result is obtained.
•Quality controls are usually run every 24 hours (on two levels of quality control), and all facilities have internal training schedules/procedures for personnel using glucose meters.

FDA very much appreciates the participation of LabNet facilities in the discussion of user experiences with glucose meters in health care settings. The feedback is very valuable. The information from this discussion will help greatly in the development of strategies to address common problems with glucose meters and to improve the safety of this device.
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Analysis of Glucose Meter Medical Device Reporting (MDR)/MAUDE database

From August 2006 to January 2007 (6-month period):
Total number of MDR reports: 4,629
Event type:
• Malfunction: 3,276 (70.8%)
• Injury: 1,259 (27.2%)
• Death: 11 (0.2%)
• Invalid data: 25 (0.5%)
• Other: 58 (1.3%)

Analysis of reported events by device problem code indicated that most MDR reports were related to “erroneous reading” or “inaccurate test results”.


Reported Events by Device Problem
(August 2006-January 2007)
Problem Percentage of Reports Received (% of n=4,629)
Test results, inaccurate 47.66
Test results, high 16.33
NOT APPLICABLE14.47
Control settings incorrect 12.49
Error message given 8.81
Device, incorrect care/use of7.86
Other(for use when an appropriate device code cannot be identified7.50
Results incorrect4.90
Measurements, inaccurate4.80
Procedure, improper/incorrect4.13
Test results, low 3.24
Power-up, failure to 3.00
Readings, high 2.87
Expiration date exceeded 1.97
Device failure 1.94
Display, failure to 1.86
Malfunction 1.71
Self-activation/keying 1.62
False readings 1.06
Readings, unable to obtain 0.99
Display, incorrect 0.91
Measurements, incorrect 0.89
Components, missing 0.73
Computer software error 0.69
Melts 0.67
Readings, low0.67
Unknown (for use when the device problem is not known)0.65
Locking mechanism failure 0.52
Blank screen0.32
Packaging, unsealed0.32
Display, erratic0.30
Nonstandard0.24
Leak(s)0.22
Therapeutic results, unexpected0.19
Device, defective 0.19
Lockout mechanism failure0.13
Continuous mode failure 0.04
Product, incorrect 0.04
Programming calculations, incorrect0.04
Packaging, incomplete/missing0.04
Separate, failure to 0.04
Contamination 0.02
Imprecision 0.02
Deliver, failure to 0.02

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FDA Clears First Test Designed to Detect and Identify 12 Respiratory Viruses from Single Sample
The U.S. Food and Drug Administration today cleared for marketing a test that simultaneously detects and identifies 12 specific respiratory viruses.

For full article text, visit: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01770.html
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FDA Clears First Quick Test For Drug-Resistant Staph Infections Test Identifies MRSA Bacterium in Two Hours

The U.S. Food and Drug Administration (FDA) today announced it has cleared for marketing the first rapid blood test for the drug-resistant staph bacterium known as MRSA (methicillin-resistant Staphylococcus aureus), which can cause potentially deadly infections.
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Group Issues Consensus Statement on HbA1C Standardization
Clinical Laboratory News
By: Deborah Levenson

The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and three diabetes groups have released a consensus statement calling for worldwide standardization of hemoglobin (HbA1c) test results through adoption of the IFCC reference method.

Additional Information:

Reporting Problems with Glucose Meters and Continuous Glucose Monitoring Systems
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/GlucoseTestingDevices/ucm162002.htm

Visit the following webpage for helpful tips
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/GlucoseTestingDevices/default.htm

Draft Guidance for Industry and FDA Staff - Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm079138.htm

FDA Clears First Test Designed to Detect and Identify 12 Respiratory Viruses from Single Sample
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116829.htm

FDA Clears First Quick Test For Drug-Resistant Staph Infections Test Identifies MRSA Bacterium in Two Hours
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm161552.htm

Group Issues Consensus Statement on HbA1C Standardization
http://www.aacc.org/publications/cln/2007/nov/Pages/inside1_1107.aspx


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