MAUDE Adverse Event Report: ABBOTT DIABETES CARE LTD FREESTYLE LIBRELINK; CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number 71732-01

Device Problems Device Alarm System (1012); Application Program Problem (2880)

Patient Problems Hypoglycemia (1912); Dizziness (2194)

Event Date 07/15/2023

Event Type  Injury  

Manufacturer Narrative

Extended investigation is pending at this time.A follow up will be submitted once additional information is obtained.The device manufacturing date does not apply.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

An alarm issue was reported with the adc device in use with samsung galaxy a52 s 5g phone with android operating system version 12.Customer experienced a signal loss and was unable to obtain readings and receive glucose alarms.As a result, customer was not alerted of changes in glucose level and experienced hypoglycemia with symptoms described as dizziness and was unable to self-treat, requiring treatment with unspecified fluids by third-party.There was no report of death or permanent impairment associated with this event.

Event Description

An alarm issue was reported with the adc device in use with samsung galaxy a52 s 5g phone with android operating system version 12, app version 3.4.2.9593.Customer experienced a signal loss and was unable to obtain readings and receive glucose alarms.As a result, customer was not alerted of changes in glucose level and experienced hypoglycemia with symptoms described as dizziness and was unable to self-treat, requiring treatment with unspecified fluids by third-party.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

The freestyle libre 3 complaint was investigated and determined that there were no issues with the libre 3 application that would have led to the complaint.The user reported missing high and low alarms due to signal loss.Attempted to replicate the user¿s complaint using similar configuration of samsung galaxy note 10, android 12, 3.4.2.9593 and the reported issue was unable to be replicated and the system functioned as intended.Therefore, this complaint is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREESTYLE LIBRELINK
• Type of Device: CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE LTD; range road; witney CA 12345 -700; UK 12345-7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 17595943
• MDR Text Key: 321647649
• Report Number: 2954323-2023-36961
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: VERIFY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71732-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/08/2023
• Initial Date FDA Received: 08/22/2023
• Supplement Dates Manufacturer Received: 11/13/2023
• Supplement Dates FDA Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention