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Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx… recallZ-0929-2020 · Dexcom Inc · initiated Jul 12, 2019

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

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 root cause category: Software design

What the company is doing

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

Recall details

Recall number
Z-0929-2020
Status
Terminated
Initiated by the company
Jul 12, 2019
Recalling firm
Dexcom Inc
Quantity
112,415 receivers
Product code
MDS
FDA submissions
P120005S033
Distribution
US Nationwide distribution.

Product description

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 (models, lots, serial numbers)

Show the full code information (1k characters)

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

Devices named in this recall

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

Product lines

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