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Dexcom Inc recalls Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, containing software version SW10617 and revision 4.0.1.048

Recalled February 12, 2020 · FDA recall Z-0929-2020 · Dexcom

Hazard
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 Class II
Units
112,415 receivers
Sold at
US Nationwide distribution.

Description

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.

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.
Manufacturer(s)
Dexcom Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

Dexcom Inc recalls Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, containing software version SW10617 and revision 4.0.1.048 | RecallWatchUSA