MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71857-01

Device Problems Device Alarm System (1012); No Audible Alarm (1019)

Patient Problem Insufficient Information (4580)

Event Date 01/06/2023

Event Type  Injury  

Event Description

An alarm issue was reported with the adc device.The low and high glucose alarms did not sound and customer was not alerted of changes in glucose level.As a result, the customer required unspecified third-party treatment via "injection".No further information regarding the treatment was provided.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

The customer¿s product data has been requested for investigation.A follow-up report will be filed once additional information is obtained.Per smartphone compatibility information, with use of application, the customer's device (phone) has not been tested for compatibility at the time of investigation.The compatibility guide states that abbott diabetes care has not assessed compatibility on phone/operating systems other than those listed.This guide is available to the user on the websites where the product is launched.Therefore, this issue is not confirmed.The date of event is unknown.The date entered is the date abbott diabetes care became aware of the event.The device manufacturing date is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Manufacturer Narrative

The user reported that they are unable to receive notifications in freestyle libre 2 application.An extended investigation performed and determined that there were no issues with the freestyle libre 2 application that would have led to the complaint.Attempts to replicate the users complaint using a similar configuration was performed and was not able to reproduce the complaint.Thus, this is complaint is not confirmed.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.

Event Description

An alarm issue was reported with the adc device.The low and high glucose alarms did not sound and customer was not alerted of changes in glucose level.As a result, the customer required unspecified third-party treatment via "injection." no further information regarding the treatment was provided.There was no report of death or permanent injury associated with this event.

Event Description

An alarm issue was reported with the adc application in use with a samsung galaxy (b)(6) phone android 13 operating system.The low and high glucose alarms did not sound and customer was not alerted of changes in glucose level.As a result, the customer required unspecified third-party treatment via "injection." no further information regarding the treatment was provided.There was no report of death or permanent injury associated with this event.The impacted product associated with this complaint is on market in the united states as well as the following countries ous: au, at, be, hr, cz, dk, fi, fr, de, gr, il, it, kw, lu, nl, nz, no, pl, pt, qa, sa, es, se, ch, tw, ae, gb, ca.Field action fa1010-2023 was issued to all impacted countries 08feb23.

Manufacturer Narrative

Adc has identified a software defect for the freestyle libre 2 application with the ( samsung galaxy (b)(6)) android 13 os where the application may experience intermittent signal loss.As a result, the application user may not receive glucose results and/or glucose alarms and may not be alerted of low or high glucose conditions.Based on the investigation, this complaint is confirmed.This issue was addressed in the field by adc fa1010-2023.The device mfg date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.Related b3 comment as applicable: the date of event is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREESTYLE LIBRE 2
• Type of Device: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 16179232
• MDR Text Key: 307465514
• Report Number: 2954323-2023-02573
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K210943
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71857-01
• Device Catalogue Number: 71857-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: QUALITY RECORD QR869957
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention