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U.S. Department of Health and Human Services

Medical Devices

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Reporting Problems with Laboratory Tests and Equipment

Once an IVD device goes into widespread use, unforeseen problems can arise. FDA's premarket review cannot always detect adverse events that are rare or if the problems are related to the clinical use of the device, manufacturing problems, product labeling (including instructions for use), or user technique and skill. To identify these problems, FDA and manufacturers depend on reports from the individuals and facilities that use IVD devices.

What types of problems should be reported?

  • Device problems including
    • reagent or instrument failure
    • defects in product design or development
    • 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 IVD device problems?

  • 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 IVD device 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 (false positive or false negative),
    • unexplained quality control (QC) failures,
    • inaccurate or unreadable instructions for use,
    • packaging or product mix-up,
    • contamination or stability problems,
    • 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 IVD device problems be reported?

If you want to notify OIVD directly of a problem with a laboratory test or other equipment, contact us at fdalabtest@cdrh.fda.gov.

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 IVD device 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