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

Model Number 72081-01

Device Problem Device Alarm System (1012)

Patient Problems Hemorrhage/Bleeding (1888); Loss of consciousness (2418)

Event Date 02/16/2023

Event Type  Injury  

Manufacturer Narrative

The product has been requested for investigation.A follow-up report will be submitted once additional information is obtained.The device mfg date is unknown.The date entered is the date abbott diabetes care became aware of the event.N/a was selected, as it is unknown if the user was using android, ios, or a reader with a fs libre 3 sensor.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Abbott diabetes care (adc) received a complaint via email which indicated that while using the freestyle libre 3 app, a "signal loss" issue was encountered and the alarm failed to trigger when they became hypoglycemic.The customer experienced a loss of consciousness that resulted in a fall and they started to bleed from the laceration.The customer further reported being unable to self-treat and had contact with a healthcare professional who provided unspecified medical treatment.No further information was provided.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.The dhrs (device history review) for the libre sensor and libre sensor kits were reviewed and the dhrs showed the libre sensor and libre sensor kits passed all tests prior to release.Sensor (b)(6) has been returned and investigated.Visual inspection performed on the returned sensor patch and no issue was observed.Data was extracted using approved software, and extraction was successful.Watermark was observed at the base of the tail indicating the sensor being properly inserted.The sensor was restored to storage state and activated with a known good reader to receive first 5 ble (bluetooth low energy) packets and first 5 ble packets were received.The blc count and rssi (received signal strength indicator) were present for all packets.No malfunction or product deficiency was identified.Therefore this issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Abbott diabetes care (adc) received a complaint via email which indicated that while using the freestyle libre 3 app, a "signal loss" issue was encountered and the alarm failed to trigger when they became hypoglycemic.The customer experienced a loss of consciousness that resulted in a fall and they started to bleed from the laceration.The customer further reported being unable to self-treat and had contact with a healthcare professional who provided unspecified medical treatment.No further information was provided.There was no report of death or permanent injury associated with this event.

Event Description

Abbott diabetes care (adc) received a complaint via email which indicated that while using the freestyle libre 3 app, a "signal loss" issue was encountered and the alarm failed to trigger when they became hypoglycemic.The customer experienced a loss of consciousness that resulted in a fall and they started to bleed from the laceration.The customer further reported being unable to self-treat and had contact with a healthcare professional who provided unspecified medical treatment.No further information was provided.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.Visual inspection performed on the returned sensor patch and no issue was observed.Data was extracted using approved software, and extraction was successful.Watermark was observed at the base of the tail indicating the sensor being properly inserted.The sensor was restored to storage state and activated with a known good reader to receive first 5 ble (bluetooth low energy) packets and first 5 ble packets were received.The blc count and rssi (received signal strength indicator) were present for all packets.Sensor state 7 with event log 11 and sensor state 8 with event log 9 are an indication that the sensor had terminated due to an error recognized by the sensor.This is a part of software design and is not an indication of product non-conformance.No malfunction or product deficiency was identified.Therefore this issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREESTYLE LIBRE 3
• Type of Device: 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, CA 94502-7001 ; 5107495297
• MDR Report Key: 16541539
• MDR Text Key: 311288970
• Report Number: 2954323-2023-10277
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• 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: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2023
• Device Model Number: 72081-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2022
• 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