BEUDAMED
    FDA Recall Open, Classified

    Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 (MT27409-1), STK-DO-013 (MT27409-1), STK-DO-103 (MT27409-2), STK-DO-109 (MT27409-2)

    Recall: Z-1946-2025 · Initiated May 12, 2025

    Recall

    Recall Number
    Z-1946-2025
    Event Number
    96743
    Firm
    Dexcom, Inc.
    FEI Number
    3004753838
    Product Code
    QBJ
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 12, 2025
    Posted
    June 16, 2025
    Address
    6340 Sequence Dr, San Diego, CA, 92121-4356

    Description

    Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 (MT27409-1), STK-DO-013 (MT27409-1), STK-DO-103 (MT27409-2), STK-DO-109 (MT27409-2)

    Reason

    Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death.

    Action

    On May 12, 2025, Dexcom issued a "Urgent: Medical Device Correction" Notification to affected consignees via E-Mail. On June 9, 2025, Dexcom issued an Urgent: Medical Device Correction update Dexcom asked consignees to take the following actions: 1. Verify if your receiver is affected by this issue: Check the serial number for any receiver(s) you use: https://dexcom.com/en-us/checkreceiver 2. If your receiver is affected, contact Dexcom Technical Support at 1-844-478-1600 to coordinate return of the affected receiver and a no charge replacement. 3. Whether or not your receiver is affected by this notification, Dexcom continues to recommend regular testing of the speaker. Test speaker function every time you charge your receiver. When you charge, a reminder prompt will invite you to test speaker function. 4.If you need assistance related to this issue or notification, please call Dexcom Technical Support at 1- 844-478-1600. Technical Support is available 24 hours a day/7 days a week to assist you.

    Distribution

    worldwide distribution - US Nationwide and the countries of Andorra, Argentina Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, New Zealand, Norway, Oman, Poland, Romania, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom.

    Quantity

    38,127 units