Reporting Problems with Glucose Meters and Continuous Glucose Monitoring Systems

This section will provide you with a least burdensome way of reporting the problems you may encounter when using your Glucose Meter or your Continuous Glucose Monitoring System (CGMS).

If you would like to notify FDA directly about a problem with a glucose meter or a CGMS, contact the Office of In Vitro Diagnostics at glucose@fda.hhs.gov. In your e-mail, please include as much of the following information as possible:

1. Brand of the meter or GGMS involved (and the model or catalog number, if known).
2. Lot number of the test strip or sensor involved.
3. Date of the event.
4. Whether you are the patient or family member or a healthcare professional.
5. Whether or not the manufacturer was notified about the problem
6. The patient's age
7. Description of patient’s symptoms at the time of the event.
8. 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, was the repeat testing 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 performed by a healthcare facility.

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

To identify these problems, 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
• 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 that cause or contributed to an incorrect patient diagnosis and/or treatment

Use-related problems including

• inadequate and/or misleading labeling or confusing user instructions
• 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 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 FDA whenever it is suspected that the product caused or contributed to an adverse outcome. FDA is interested in reports of:
  • product problems such as erroneous results (falsely elevated or decreased glucose results),
  • unexplained quality control (QC) failures,
  • inaccurate or unreadable instructions for use,
  • packaging or product mix-up,
  • contamination or stability problems with the quality control solutions or test strips,
  • defective devices,
  • product confusion caused by name, labeling, design, or packaging,
  • "near misses" where under slightly different circumstances, a serious injury or death might have occurred, or
  • use error

How should problems with glucose meters and CGMSs be reported?

• Mandatory Reporting by User Facilities (MDR)
• Voluntary Reporting by Consumers (MedWatch)
• Voluntary Reporting by Healthcare Professionals (MedWatch)

What happens to your report?

When FDA receives a report from a user facility, device user or an individual healthcare professional, it is entered in the medical device postmarket surveillance database. FDA continually reviews the database to detect problems, trends, and potential hazards. When 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?

FDA is aware that glucose meter and CGMS users are concerned about the issue of confidentiality and public availability of reports. For all reports, FDA holds the patient's identity in strict confidence and protects it to the fullest extent of the law. 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, FDA will not disclose the reporter's identity in response to a request from the public, pursuant to the Freedom of Information Act.

See also:

Medical Device Reporting for User Facilities

MedWatch: The FDA Safety Information and Adverse Event Reporting Program