Recall Z-0929-2020 ยท MDS Sensor, Glucose, Invasive
Dexcom Inc
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 device
| Date | Jul 12, 2019 |
| Status | Terminated |
| Reason | 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 bu |
| Root cause | 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 Recei |
| Quantity | 112,415 receivers |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.