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U.S. Department of Health and Human Services

Class 2 Device Recall Dexcom G6 Continuous Glucose Monitoring System

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  Class 2 Device Recall Dexcom G6 Continuous Glucose Monitoring System see related information
Date Initiated by Firm February 03, 2020
Create Date March 25, 2020
Recall Status1 Terminated 3 on January 20, 2022
Recall Number Z-1562-2020
Recall Event ID 84891
510(K)Number K191450  
Product Classification Integrated Continuous Glucose Monitoring system, factory calibrated - Product Code QBJ
Product Dexcom G6 Continuous Glucose Monitoring System

The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes.
Code Information Device Listing Number: D319131  Model: STS-OR-003 Description: G6 Sensor Kit 3 Pack GUDID Registered GTIN: 50386270000250 Lot Number: All  Model: STS-OE-003 Description: G6 Sensor Kit 3 Pack Retail GUDID Registered GTIN: 00386270000866 Lot Number: All  Model: STS-OM-003 Description: G6 Sensor Kit 3 Pack Medicare GUDID Registered GTIN: 00386270001047 Lot Number: All  Model: STS-OM-003 Description: G6 Sensor Kit 3 Pack Pro Q GUDID Registered GTIN: 70386270000254 Lot Number: All 
Recalling Firm/
Manufacturer		 Dexcom Inc
6340 Sequence Dr
San Diego CA 92121-4356
For Additional Information Contact Anita Rees
858-875-9463
Manufacturer Reason
for Recall		 The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may falsely elevate glucose readings on the Continuous Glucose Monitoring Systems.
FDA Determined
Cause 2		 Under Investigation by firm
Action Starting in February 2020, the firm will add an "URGENT MEDICAL DEVICE CORRECTION" Notification to sensor packaging informing valued customers that the firm recently became aware that hydroxyurea, an anti-neoplastic drug used primarily in chemotherapy, falsely elevates glucose readings on its Continuous Glucose Monitoring (CGM) Systems. This may result in failure to treat hypoglycemia from missed low sensor glucose values and alerts or by causing other errors in diabetes management decisions (for example, hypoglycemia resulting from an insulin dose based on a falsely elevated sensor glucose reading). Some examples of the disease states that hydroxyurea is more commonly used in include: -Chronic Myelogenous Leukemia (CML) -Head and neck malignancies, and -Sickle cell disease The Recalling Firm is instructing its customers to not use their CGM System for diabetes treatment decisions if they are taking hydroxyurea. Customers are instructed to talk to their physician about alternative glucose monitoring approaches, and if they are unsure if they have been prescribed hydroxyurea. The Recalling Firm is currently updating their product labelling as following: "Hydroxyurea is a medication used in the treatment of diseases including cancer and sickle cell anemia; it is known to interfere with readings from your sensor. If you are taking hydroxyurea, your sensor glucose readings will be higher than your actual glucose, which could result in missed hypoglycemia alerts, or errors in diabetes management, such as giving yourself a higher dose of insulin due to falsely high sensor glucose values. The level of inaccuracy depends on the amount of hydroxyurea in your body. Do not use your Dexcom CGM System for diabetes treatment decisions if you are taking hydroxyurea. Talk to your physician about alternative glucose monitoring approaches. . . .Should you have any questions regarding hydroxyurea or alternative glucose monitoring approaches, please contact your healthcare
Quantity in Commerce 275583
Distribution World-wide 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = QBJ and Original Applicant = Dexcom, Inc.
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