FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System

FDA device recall Z-0734-2024 · posted 2024-01-16 · Completed

Recall details

Recalling firm

Abbott Diabetes Care, Inc.

Reason for recall

If using affected glucose monitoring app on Android 13 Operating System, extended periods of signal loss may be experienced, due to app not connected, which could impact ability to receive glucose reading/alarms, which could lead to undetected low or high glucose, which could result in delayed treatment: not taking insulin (for high glucose), or not taking glucose (for low glucose) when required.

Action taken

On 2/9/23, an Important Message/Communication was sent to customers informing them of the following: If you experience extended periods of signal loss, either of the following actions should allow reconnection: 1) Turn your smartphone's Bluetooth OFF and then ON 2) Turn your smartphone OFF and then ON To be notified if extended periods of signal loss occur: 1) Open your FreeStyle Libre 3 app, navigate to Alarms, and configure your signal loss alarm to be ON with "Override Do Not Disturb" enabled. 2) Please refer to www.FreeStyleAndroid.com for more information on how to configure alarms. On 2/27/23, another Important Message/Communication was sent to customers informing them that updated software version 3.4.2 was available to fix the connection issue. Questions can be directed to Customer Care team at 1-855-632-8658. The team is available 7 days a week from 8 AM to 8 PM Eastern Time, excluding holidays.

Root cause

Software design

Status

Completed

Product code

QLG

Quantity affected

45,173

Distribution

US Nationwide distribution in the states of NY, CA, NJ, UT, PA, MS, OH, TX, MN, FL, LA, NE, MI, VA, NC, MA, IN, SC, IA.

Date initiated

2023-02-09

Date posted

2024-01-16

Location

Alameda, CA

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