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U.S. Department of Health and Human Services

Class 2 Device Recall Guardian Sensor (3)

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  Class 2 Device Recall Guardian Sensor (3) see related information
Date Initiated by Firm February 26, 2021
Create Date May 17, 2021
Recall Status1 Open3, Classified
Recall Number Z-1615-2021
Recall Event ID 87476
Product Classification Sensor, glucose, invasive - Product Code MDS
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.
Code Information All Lot numbers within active shelf life
Recalling Firm/
Manufacturer		 Medtronic Inc.
18000 Devonshire St
Northridge CA 91325-1219
For Additional Information Contact Pamela Reese
818-576-4700
Manufacturer Reason
for Recall		 Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
FDA Determined
Cause 2		 Under Investigation by firm
Action 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
Quantity in Commerce 12,624 units
Distribution Worldwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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