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U.S. Department of Health and Human Services

Class 2 Device Recall Dexcom G5 Mobile Receiver

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  Class 2 Device Recall Dexcom G5 Mobile Receiver see related information
Date Initiated by Firm July 12, 2019
Create Date January 31, 2020
Recall Status1 Open3, Classified
Recall Number Z-0929-2020
Recall Event ID 84290
PMA Number P120005S033 
Product Classification Sensor, glucose, invasive - Product Code MDS
Product 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 information, facilitating long-term therapy adjustments.
Code Information All serial numbers of the G5 Mobile Receivers with software version SW10617 and software revision 4.0.1.048  Receiver Part Number/Reciver Kit Number/GUDID registered GTINS/ Receiver Kit Type:  Dexcom G5 Mobile Receiver, MT22179 (BLK) Rev 013 and Rev 014 Receiver (mg/dL), Black  STK-GF-001/ 10386270000238 - Starter Kit STK-RF-001/20386270000235 - Retail Starter Kit STR-GF-001/30386270000232 - Replacement Receiver Kit STK-GF-IUO/NA - Investigational Use STK-MC-001/00386270000606 - Medicare Starter Kit  Dexcom G5 Mobile Receiver, MT22719 (PNK) Rev 012 and 013, Receiver (mg/dL), Pink STK-GF-PNK/ 30386270000263 - Starter Kit STK-RF-PNK/10386270000269 - Retail Starter Kit STR-GF-PNK/20386270000266 - Replacement Receiver Kit  Dexcom G5 Mobile Receiver, MT22719 (BLU) Rev 012 and 013, Receiver (mg/dL), Blue STK-GF-BLU/ 30386270000270 - Starter Kit STK-RF-BLU/10386270000276 - Retail Starter Kit STR-GF-BLU/20386270000273 - Replacement Receiver Kit   
Recalling Firm/
Manufacturer
Dexcom Inc
6340 Sequence Dr
San Diego CA 92121-4356
For Additional Information Contact Dexcom Technical Support
877-339-2664
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Software design
Action 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
Quantity in Commerce 112,415 receivers
Distribution US Nationwide 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = MDS and Original Applicant = DEXCOM, INC.
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