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U.S. Department of Health and Human Services

Medical Devices

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How to Report Problems with Glucose Meters and Continuous Glucose Monitoring Systems

This section will provide you with information on how to report problems you may encounter when using your glucose meter or your continuous glucose monitoring system (CGMS).

If you would like to notify the FDA directly about a problem with a glucose meter or a CGMS, contact us using the information at the bottom of this page. In your e-mail, please include as much of the following information as possible:

  • brand of the meter or GGMS involved (and the model or catalog number, if known)
  • lot number of the test strip or sensor involved
  • date of the event
  • whether you are the patient or family member or a health care provider
  • whether or not the manufacturer was notified about the problem
  • the patient's age
  • description of patient’s symptoms at the time of the event
  • description of the event, such as:
    • initial meter or CGMS test result
    • If the test was repeated, provide the test result(s) and indicate how long after the initial test the repeat testing was performed (e.g., 10 minutes later).
    • Indicate whether the same testing device was used for repeat testing or if a different glucose testing device was used. If different, provide any information that is known about the 2nd testing device. Be sure to specify if any of testing was performed by a health care facility.

Once a glucose meter or a CGMS goes into widespread use, unforeseen problems may arise because the FDA's clearance and approval processes cannot always detect adverse events that are rare or related to the clinical use of the device or the users’ techniques and skills. The FDA also cannot always detect manufacturing problems or problems with the product labeling (including instructions for use) until after the device is on the market.

To identify these problems, the FDA and manufacturers depend on reports from the individuals who use glucose meters or CGMSs.

What types of problems should be reported?

Device problems including:
  • reagent or instrument failure/defective devices
  • defects in product design
  • product instability
  • any other device problems that compromise patient health or safety
  • failure to perform according to performance characterized in package insert
  • incorrect test results (falsely elevated or decreased glucose results) that cause or contributed to an incorrect patient diagnosis and/or treatment
  • unexplained quality control (QC) failures, contamination or stability problems with the quality control solutions or test strips
  • "near misses" where under slightly different circumstances, a serious injury or death might have occurred, or use error
Use-related problems including:
  • inadequate and/or misleading labeling or confusing user instructions
  • product confusion caused by name, labeling, design, or packaging
  • inadequate packaging or poor package design
  • any other user problems that compromise patient health or safety

Who should report problems with glucose meters and CGMSs?

  • User facilities, including hospitals, ambulatory surgical facilities, nursing homes, outpatient treatment facilities, or outpatient diagnostic facilities are required to report:
    • device-related events that have caused, or may have caused or contributed to a death to both the FDA and the manufacturer
    • device-related events that have caused, or may have caused or contributed to a serious illness or injury to the manufacturer. If the medical device manufacturer is unknown, the serious injury is reported by the facility to the FDA.
  • All other glucose meter and CGMS users, including doctors and patients, are encouraged to voluntarily report device problems directly to the manufacturer and/or the FDA whenever it is suspected that the product caused or contributed to an adverse outcome.

What happens to your report?

When the FDA receives a report from a user facility, device user or an individual health care provider, it is entered in the medical device postmarket surveillance database. The FDA continually reviews the database to detect problems, trends, and potential hazards. When the FDA detects risks or potential risks associated with the use of a particular product, the agency can take corrective actions and notify the public.

Who has access to your report?

The FDA is aware that glucose meter and CGMS users are concerned about the issue of confidentiality and public availability of reports. For all reports, the FDA holds the patient's identity in strict confidence and protects it to the fullest extent of the law. The FDA will not release any patient identifiers to the public. Reporters can assist in this process by not using the patient's name, initials, or other identifying information. The reporter's identity, including the identity of a self-reporter, may be shared with the manufacturer unless requested otherwise (there is a check-off box on the report form). However, the FDA will not disclose the reporter's identity in response to a request from the public, pursuant to the Freedom of Information Act.

How do you Report a Problem?

Problems can be reported through the MedWatch Online Voluntary Reporting Form

 

Contact FDA

301-796-5450
CDRH-Office of In Vitro Diagnostics and Radiological Health

Center for Devices and Radiological Health

10903 New Hampshire Avenue

WO66-5521

Silver Spring, MD 20993