The Recall Desk
HighFDA (Devices)·Z-0929-2020·Announced 2020-02-12

Dexcom G5 Mobile Receiver Recalled for Software Glitches

Dexcom Inc is recalling 112,415 G5 Mobile Receivers due to software issues that may prevent patients from receiving glucose values or alerts.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device where a software defect prevents the delivery of critical glucose data and alerts, creating a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.

Plain-English summary

Dexcom Inc is recalling 112,415 Dexcom G5 Mobile Receivers distributed nationwide in the United States. The affected devices are identified by specific part numbers (MT22179, MT22719) and contain software version SW10617 with revision 4.0.1.048. These devices are intended to determine glucose levels and the direction and rate of change of glucose levels in people with diabetes, replacing standard blood glucose monitoring for treatment decisions.

The recall is due to reported software malfunctions. Users have reported that the receiver may become stuck on the initialization screen when powering on, which prevents patients from receiving glucose values or alerts. Additionally, the receiver may reinitialize without user interaction. In such cases, the device may reboot and operate normally, or it may require the user to press the Select button to resume operation. Until the button is pressed, patients will not receive glucose values or alerts, though they will receive audio and vibratory alerts every five minutes.

The recalled product

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 peo
Manufacturer
Dexcom Inc
Category
Medical Device — Glucose Monitoring
Hazard
Affected units
112,415

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • MT22179 (BLK) Rev 013 and Rev 014 Receiver (mg/dL)
  • MT22719 (PNK) Rev 012 and 013
  • Receiver (mg/dL)
  • MT22719 (BLU) Rev 012 and 013

Distribution

Distributed nationwide across the United States.

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