FDA Issues Diabetes Device Warning After Serious Adverse Event

The Food and Drug Administration (FDA) has warned health care providers and patients about the risks of using unauthorized devices for diabetes management, such as continuous glucose monitoring systems (CGMS), insulin pumps and automated insulin dosing systems.

Unauthorized diabetes devices have not been reviewed by the FDA; these include stand alone devices as well as those used in conjunction with other devices.

The Agency disclosed that they received a serious adverse event report detailing a patient who used an unauthorized device. The device receives an electronic signal from an FDA authorized glucose sensor and converts it to a glucose value using an unauthorized algorithm. This resulted in the system giving a patient too much insulin in response to incorrect glucose values, leading to the patient requiring medical intervention for insulin overdose.

Authorized automated insulin dosing systems include a specific continuous glucose monitoring system, a specific insulin pump, and a specific algorithm. Integrated continuous glucose monitoring systems and “automated controller enabled” insulin pumps have recently been authorized to work safely with other devices, and are labeled to indicate which devices can be safely used together.

To prevent further adverse events health care providers are recommended to:

  • Be aware that the FDA has not evaluated the safety and effectiveness of unauthorized diabetes management devices or the safety and effectiveness of systems that combine devices in unintended ways.
  • Be aware that your patients should only use diabetes management devices the FDA has authorized for sale in the US and should use them according to manufacturer instructions.
  • Report any patients experience of adverse events associated with the use of any diabetes management device, whether authorized or unauthorized, to MedWatch.

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In a statement the FDA said they will, “Continue to closely monitor adverse event reports associated with diabetes management devices and will take additional steps as necessary [and] will update this communication if significant new information becomes available.”

For more information visit FDA.gov.