MAUDE Adverse Event Report: ABBOTT DIABETES CARE LTD FREESTYLE LIBRE 3; CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number	72075-01
Medical Device Problem Codes	Device Alarm System (1012); Application Program Problem (2880)
Health Effect - Clinical Codes	Hypoglycemia (1912); Diaphoresis (2452)
Date of Event	09/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
An alarm issue was reported with the abbott diabetes care (adc) device in use with samsung phone with android operating system version 14.The customer experienced a signal loss and was unable to receive glucose alarms.As a result, the customer was not alerted of changes in glucose level and experienced sweating and was unable to self-treat, requiring treatment of an "okluko" injection by healthcare professional (friend).There was no report of death or permanent impairment associated with this event.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
An extended investigation has been performed for the reported complaint.The customer reported for signal loss.Sensor was inserted in the simvivo test fixture.The app was downloaded and initial app setup was completed.Sensor was scanned by the app and enabled ¿signal loss alarm¿ feature in the app and placed device in faraday bag to interrupt signal to sensor.Removed device from bag and confirmed sensor was reconnected within few minutes.Alarms functioned as intended.Attempted to replicate customer complaint using similar configuration.However, the reported issue could not be replicated and the system functioned as intended under the tested conditions.Based on the customer¿s reported application, potential causes and device history were also examined, but no issues were identified during replication that could have led to the reported issue.Therefore, the issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
An alarm issue was reported with the abbott diabetes care (adc) device in use with samsung phone with android operating system version 14, app version 3.5.1.10363.The customer experienced a signal loss and was unable to receive glucose alarms.As a result, the customer was not alerted of changes in glucose level and experienced sweating and was unable to self-treat, requiring treatment of an "okluko" injection by healthcare professional (friend).There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE LIBRE 3
• Common Device Name: CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE LTD; range road; witney 12345 -700; UK 12345-7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda 94502-7001 ; 5107495297
• MDR Report Key: 20295810
• Report Number: 2954323-2024-37607
• Device Sequence Number: 7284337
• Product Code: QLG
• UDI-Device Identifier: 00357599816001
• UDI-Public: 00357599816001
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K213996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: 72075-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown