URGENT MEDICAL DEVICE CORRECTION


Sensor glucose values with use of Hydroxyurea medication


Enlite™ Sensor (MMT-7008) and Guardian™ Sensor 3 (MMT-7020)

Sensor Glucose Values with Use of Hydroxyurea Medication – Notification Download

If you are actively taking a medication named Hydroxyurea, used to treat some cancers and sickle cell anemia, your sensor could present inaccurate sensor glucose (SG) readings. Because your safety is our top priority, we are making you aware of this issue and important actions. Consult your healthcare professional if you are taking Hydroxyurea and using a CGM. Medtronic has not received any complaints or reports of patient harm or injuries due to this issue.

Explanation of issue:
Hydroxyurea is used to treat certain diseases, such as cancer and sickle cell anemia. Hydroxyurea is also known by other names, such as hydroxycarbamide, Hydrea™*, Droxia™*, and Siklos™*. Hydroxurea use results in higher SG readings compared to blood glucose (BG) readings and may result in the following:

  • Hypoglycemia caused by over-administration of insulin
  • Inaccurate graphs or missed alarms and alerts
  • Delay to or loss of sensor-enabled insulin suspension (sensor-enabled insulin pump use only)
  • SG readings in CareLink™ reports being substantially higher than BG readings

What you should do:

  • Do not use continuous glucose monitoring (CGM) while taking hydroxyurea.
  • Only use your BG meter to monitor glucose levels while taking hydroxyurea.
  • Consult with your healthcare professional if you are taking hydroxyurea and using a CGM.
  • When using an insulin pump system, disable the CGM feature by going to the sensor settings. Refer to the user guide that came with your insulin pump for instructions.
  • Always check the label of any medication to confirm with your healthcare professional whether hydroxyurea or hydroxycarbamide is an active ingredient.

What Medtronic is doing:

Medtronic is working to update instructions for use of CGM sensors to include warnings about use of CGM while taking Hydroxyurea.

At Medtronic, patient safety, awareness and customer satisfaction are our top priorities. We apologize for any inconvenience this issue may cause you and appreciate your time and attention in reading this important notification.

As always, we are here to support you. If you have further questions or need assistance, please call 24-Hour Technical Support line at: 800-646-4633, option 1.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.


† Includes these variants for Enlite™ sensors (MMT-7008A, MMT-7008B) and Guardian™ Sensor 3 sensors (MMT-7020LA, MMT-7020LB, MMT-7020LPA, MMT-7020A, MMT-7020B, MMT-7020GA, MMT-7020Y, MMT-7020YL)


Frequently asked questions


Yes, by definition in the United States, the action being taken is considered a Correction. Given we are updating labeling to include a warning and issue a notification to customers, it is considered a recall. In this instance, a “recall” means you should stop using continuous glucose monitoring (CGM) while taking hydroxyurea. Consult with your healthcare professional if you are taking hydroxyurea and using CGM. Please follow the actions outlined in the “Urgent Medical Device Correction” notification as soon as possible.

Please follow the actions outlined in the “Urgent Medical Device Correction” notification as soon as possible. This includes the following:

  • Do not use continuous glucose monitoring (CGM) while taking hydroxyurea.
  • Only use your BG meter to monitor glucose levels while taking hydroxyurea.
  • Consult with your healthcare professional if you are taking hydroxyurea and using CGM.
  • When using an insulin pump system, disable the CGM feature by going to the sensor settings. Refer to the user guide that came with your insulin pump for instructions.
  • Always check the label of any medication to confirm with your healthcare professional whether hydroxyurea or hydroxycarbamide is an active ingredient.
Hydroxyurea is used to treat disease conditions such as cancer and sickle cell anemia and is not a commonly used, first-option medication. Per U.S. national patient database search, the prevalence of Hydroxyurea usage among type-1 diabetes patients using CGM is 0.033%.
This issue affects Enlite™ sensor and Guardian™ Sensor 3, including when used in connection with Medtronic insulin delivery pumps, standalone CGM systems, and software.
No, your sensor does not require replacement. Please consult with your healthcare professional if you are taking Hydroxyurea and using CGM.
At Medtronic, customer safety, awareness and customer satisfaction are our top priorities. Although Hydroxyurea is not a commonly used medication, we are proactively notifying customers and healthcare professionals potentially affected by this issue.