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

Model Number 71992-01

Device Problem Device Alarm System (1012)

Patient Problems Hypoglycemia (1912); Diaphoresis (2452); Confusion/ Disorientation (2553)

Event Date 03/25/2024

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The device manufacturing date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.This is 1 of 2 submission report.All pertinent information available to abbott diabetes care has been submitted.

Event Description

An alarm issue was reported with the abbott diabetes care (adc) device.The customer experienced a signal loss and was unable to obtain readings and receive glucose alarms.As a result, the customer was not alerted of changes in glucose level and experienced sweating and confusion.The customer received glucagon from a non-healthcare professional for treatment.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

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 freestyle librelink complaint was investigated and determined that there were no issues with the librelink application that would have led to the complaint.The user reported missing alarms due to signal loss.The reported issue was investigated and attempted to replicate using similar configuration and the reported issue was unable to be replicated and the system functioned as intended.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.All pertinent information available to abbott diabetes care has been submitted.

Event Description

An alarm issue was reported with the abbott diabetes care (adc) device in use with iphone with ios operating system with app version 2.10.2.7677.The customer experienced a signal loss and was unable to obtain readings and receive glucose alarms.As a result, the customer was not alerted of changes in glucose level and experienced sweating and confusion.The customer received glucagon from a non-healthcare professional for treatment.There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE LIBRE 2
• Type of Device: FLASH GLUCOSE MONITORING 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: 19145228
• MDR Text Key: 340615162
• Report Number: 2954323-2024-13522
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 05021791002504
• UDI-Public: (01)05021791002504(17)2025-01-31(10)KTP007550(91)71990-01
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K193371
• 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: 05/16/2024

1 Device was Involved in the Event

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: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Supplement Dates Manufacturer Received: 05/05/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention