FDAJuly 12, 2019device

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....

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

dexcom

UPCs

10386270000238203862700002353038627000023200386270000606303862700002631038627000026920386270000266303862700002701038627000027620386270000273

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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