MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRELINK; DATA MANAGEMENT SYSTEM

Model Number 71732-01

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

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 03/08/2024

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 the samsung g975f phone with android operating system version 9.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 loss of consciousness and was unable to self-treat, requiring treatment of glucagon by third-party.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.The sensor plug was properly seated, and no physical damage was observed on the sensor patch.The sensor was found to be in state 5 (indicating normal termination).Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.The sensor was activated with a known good reader and the bluetooth connection was successful.A linearity test was performed while the reader was wrapped in aluminum foil (to simulate signal loss), and signal loss message was observed.Sensor was scanned with reader to re-establish bluetooth connection and then was placed at a distance from the sensor.Signal loss message was not displayed.Therefore, the issue is not confirmed.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs (device history review) for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and sensor kit passed all tests prior to release.The user reported signal loss.Attempted to replicate the reported issue with the similar configuration but unable to replicate the reported complaint and the system functioned as intended.There were no issues identified with the freestyle librelink app during replication that would have led to the reported issue.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 the samsung g975f phone with android 9 operating system with app version 210110406.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 loss of consciousness and was unable to self-treat, requiring treatment of glucagon by third-party.There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE LIBRELINK
• Type of Device: DATA MANAGEMENT SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda 94502-7001 ; 5107495297
• MDR Report Key: 18948478
• MDR Text Key: 338193947
• Report Number: 2954323-2024-09485
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P160030
• 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: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• 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?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2023
• 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