BEUDAMED
    FDA Enforcement Class II Terminated

    Dexcom G4 PLATINUM 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.

    Recall: Z-1560-2020 · Reported April 1, 2020

    Enforcement

    Recall Number
    Z-1560-2020
    Event ID
    84891
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Dexcom Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    April 1, 2020
    Initiation Date
    February 3, 2020
    Classification Date
    March 25, 2020
    Termination Date
    January 20, 2022
    Address
    6340 Sequence Dr, N/A, San Diego, CA, 92121-4356, United States

    Description

    Dexcom G4 PLATINUM 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.

    Reason

    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.

    Code Info

    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

    Distribution

    World-wide Distribution

    Quantity

    3091 Systems