—#186961

Product

Medtronic REF: MMT-7020D4 Guardian Sensor (3) for the following packaging: GS3 1PK 2L CANADA/ GTIN: 00763000179595 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.

FDA product code: MDS — Sensor, Glucose, Invasive
Device class: Class 3
Medical specialty: Unknown
Affected lot / code info: All Lot numbers within active shelf life

Why it was recalled

Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On February 26, 2021, Medtronic posted the "Urgent Recall Correction" notification to their website. On March 2, 2201, Medtronic provided U.S HCPs, Patients, Distributors and globally affected Clinical trial sites with a copy of the "Urgent Recall Correction" Notification. On March 8, 2021, Medtronic provided OUS patients, HCP and distributions with a copy of the "Urgent Recall Correction" notification Communication was provided to users via: email, fax, and/or mail. In addition to informing affected users about the correction, Medtronic ask consignees to take the following actions: Do not use continuous glucose monitoring (CGM) while taking hydroxyurea. Only use their BG meter to monitor glucose levels while taking hydroxyurea. Consult with the HCP if they are taking hydroxyurea and using a CGM. When using an insulin pump system, they should disable the CGM feature by going to the sensor settings and refer to the user guide that came with the insulin pump for instructions. Always check the label of any medication and confirm with you whether or not hydroxyurea or hydroxycarbamide is an active ingredient. If further distributed, please provide those consignees with a copy of the notification. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax. " Complete and submit the report Online: www.fda.gov/medwatch/report.htm " Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Recalling firm

Firm: Medtronic Inc.
Address: 18000 Devonshire St, Northridge, California 91325-1219

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2021-02-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #186961. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.