The Recall Desk
HighFDA (Devices)·Z-0776-2023·Announced 2023-01-11

Guardian Glucose Monitoring App May Automatically Log Out and Block Data Upload

The Guardian continuous glucose-monitoring app may automatically log out, preventing data uploads and SMS alerts to care partners. This could result in missed detection of dangerous blood sugar levels.

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: This is a Class II FDA medical device recall for a continuous glucose-monitoring app. Although no illnesses or injuries have been reported, the app's failure to upload glucose data and send care-partner notifications poses a significant risk of delayed detection and treatment of dangerous blood sugar levels (hypoglycemia or hyperglycemia), meeting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Medtronic MiniMed is recalling the Guardian continuous glucose-monitoring app (versions MMT-8200 for iOS and MMT-8201 for Android) as part of the Guardian 4 system. Version 1.3.0 is affected. The recall involves 3,235 devices distributed outside the United States.

The app may automatically log out from CareLink, the cloud platform used to upload and share glucose data. When logged out, the app cannot upload glucose readings to CareLink, and linked care partners do not receive SMS notifications about the user's blood sugar levels. Additionally, sensor glucose values will not be sent to the InPen app.

This communication failure could delay detection and treatment of hypoglycemia (dangerously low blood sugar) or hyperglycemia (dangerously high blood sugar). Prompt notification of these conditions is essential for timely medical intervention. No illnesses or injuries have been reported to date.

The recalled product

Product
Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system
Manufacturer
Medtronic MiniMed
Category
Medical Device — Continuous Glucose Monitoring / Software
Hazard
  • automatic-logout
  • upload-failure
  • notification-failure

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 (1)

  • App Version 1.3.0

Distribution

Distribution scope not specified by the agency.

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