Dexcom Inc Recalls
Showing 1-4 of 4 recalls
Brand Name: Dexcom G6 CGM App for iOS Software Number: SW11677 Software Version: Version 1.4.0 up to corrected Version 1.4.4 GUDID Registered GTIN: 00386270000804
It was reported that the user's low alarm feature on the iOS application were not properly alerting users when the user has enabled the Alert Schedule feature more than 30 days after installing the iOS application.
An updated G6 iOS CGM App was placed in the Apple App Store (SW11677 version 1.4.4) with messaging pushed to all US users on November 19, 2019. The messaging repeats to the user on a daily basis until the user updates (or is alternatively blocked from use of the app if they ignore the messaging and do not update). Messaging will be delivered directly to the end user through the following App Compatibility Messaging via the Apple App Store (see Compatibility Message and time-frame below): Duration: Day 1-3 Date Range: Nov 19-21 App Compatibility Message: Warning - Please update your Dexcom G6 iOS App from the Apple App Store. Failure to update your App may cause your alarms and alerts to not work as intended. Without alarms/alerts, you might miss a severe low or high glucose event. Contact technical support if you require assistance. Duration: Day 4-17 Date Range: Nov 22 - Dec 5 App Compatibility Message: Warning - This version of the Dexcom G6 iOS App will no longer be available for use as of December 6. Update the Dexcom G6 iOS App now from the Apple App Store to continue use of the Dexcom G6 iOS App. Contact technical support if you require assistance. Duration: Day 18 Date Range: Dec 6 App Compatibility Message: Warning - This version of the Dexcom G6 iOS App is no longer available for use. Update the Dexcom G6 iOS App now from the Apple App Store to continue use of the Dexcom G6 iOS App. Contact technical support if you require assistance. For impacted users, they will receive the Alert Settings Reset notification once the app update is complete and the app is launched or the app receives a communication from the Transmitter. The user must then reset any alarm/alert customizations made (or leave at factory default settings). For users currently not impacted, they will not receive the Alert Settings Reset notification. The updated version of the app corrects the problem for those impacted and prevents the problem from occurring for
Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, containing software version SW10617 and revision 4.0.1.048 - Product Usage: A non-adjunctive invasive glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in people with diabetes. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions. The device also provides historical glucose informat
It has been reported that use of the mobile receiver with software version SW10617 rev 4.0.1.048 have reported: 1. the receiver becoming stuck on initialization screen when powering on. This will cause patients not to be able to receive glucose values or alerts; 2. Reinitialization of the receiver without user interaction. If this occurs, the receiver will either reboot and operate normally or require the user to press the Select button on the receiver in order to resume normal operation. In this situation, the user is provided an audio and vibratory alert every 5 minutes. Until the select button is pressed, patients will not receive glucose values or alerts.
On the date of August 16, 2019, Dexcom provided their consignees with an "Urgent Customer Notification - Please Read" letter concerning the recall via UPS. In addition to informing the consignees about the recall, the letter asked customers to take the following action: 1. Determine if your receiver is impacted: - The following Receiver Part Numbers are impacted (the receiver part number is located on the back of your receiver): Part Number: MT22719, Part Description: Dexcom G5 Mobile receiver (Black, Pink and Blue) 2. Determine if your software version is impacted: - Power on your Receiver - Navigate to the Main Menu - Press the Down Arrow and select Settings - Press the Down Arrow and select Device Info - The Part Number, Software Number and Software Revision are shown 3. If your Dexcom G5 Mobile Receiver software version is not 4.0.1.048, no further action is required. 4. Update Receiver Software using the Update Tool if Software Number is SW10617 and Software Revision is 4.0.1.048: - Go to: https://store.dexcom.com/user/login and sign in to your Dexcom Account. If you do not have an account, you can create one from this page. - Click on Update on the Update Tool icon: - You will be taken through a series of steps to update, which will take less than 15 minutes. - When the Update Tool download progress displays 'Update Verified ... all done', your Receiver will reboot and the Time/Date settings screen will display. At this point, the software download is complete. Confirm the date and time, and you can use your updated receiver. - For questions, please reference the Update Tool FAQs: https://www.dexcom.com/faq/how-do-i-install-update-tool 5. If your Dexcom G5 Mobile Receiver is not available, you can alternatively use the Dexcom G5 Mobile App to receive your glucose readings and alerts. This can be installed on your compatible smartphone by visiting the Apple Store or Google Play Store. For compatible devices and operating system
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.
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.
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
Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.
Dexcom sent out a customer notification letter by certified mail to all direct customers on 02/23/16 notifying customers that they may not receive an intended audible alarm or alert if relying on hearing the alarm or alert. As a result customers may not detect a severe hypoglycemic (low glucose) or hyperglycemic (high glucose) event. The letter instructs the customer to peridically test the alarms and alerts on their receiver to make sure that the alarms and alerts are functioning properly (especially if the receiver gets wet of is dropped). Receiver part numbers and instructions for testing the alarms and alerts can be found on the back of the notification as well as in the User's Guide. Should customers find that alarms and alerts are not functioning properly or if any questions regarding the notification contact the deciated hotline tool free at 844-607-8398 or dial 858-291-1700. The healthcare professional notification that was sent out provided similar instructions as the direct customer notificaiton in which it is recommended that healthcare professionals periodically check the speaker function by following the testing instructions attached in the notification. The distributor notification letter instructed them to take the following actions: Hold shipments of Dexcom receivers and sticker all existing Dexcom receiver boxes on the outside front of the box with the enclosed notification stickers (see the attached visual guide for sticker placement). Once completed can begin shipping the products. In order to ensure that the notification is timely received by patients select one of the following two (2) options by no later than February 25, 2016: Send, via certified mail, the notification directly to those patients that have purchased a Dexcom receiver from you. If elect this option, Dexcom will provide the required quantity of notifications enclosed in certified mail envelopes. In order to facilitate this effort email the number of notifi