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Dexcom G4 Platinum recallZ-1561-2020 · Dexcom Inc · initiated Feb 3, 2020

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Dexcom Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Under Investigation by firm

What the company is doing

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

Recall details

Recall number
Z-1561-2020
Status
Terminated
Initiated by the company
Feb 3, 2020
Recalling firm
Dexcom Inc
Quantity
85529 Systems
Product code
PQF
FDA submissions
P120005
Distribution
World-wide Distribution

Product description

Dexcom G5 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 (models, lots, serial numbers)

Device Listing Number: D189069  Model: STS-GL-041 Description: G4/G5 Sensor Kit 4 Pack GUDID Registered GTIN: 30386270000010 Lot Number: All  Model: STS-RX-041 Description: G4/G5 Sensor Kit 4 Pack Retail GUDID Registered GTIN: 20386270000013 Lot Number: All  Model: STS-MC-004 Description: G4/G5 Sensor Kit 4 Pack Medicare GUDID Registered GTIN: 00386270000637 Lot Number: All

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

66 devices cleared under P120005 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 84891).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page