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

Model Number 72081-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Pain (1994)

Event Date 09/16/2022

Event Type  Injury  

Event Description

A customer reported that upon wearing the adc device, they experienced pain and hematoma at the sensor site.The customer indicated receiving unspecified treatment from a healthcare professional.However, the customer declined to provide any additional information.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

At this time product has not yet been returned.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.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The date of event is unknown.The date entered is the date abbott diabetes care became aware of the event.N/a was selected for date rec¿d by mfr as it is unknown if the user was using android, ios, or a reader with the fs libre 3 sensor.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported that upon wearing the adc device, they experienced pain and hematoma at the sensor site.The customer indicated receiving unspecified treatment from a healthcare professional.However, the customer declined to provide any additional information.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

See section h11 (corrected data).All pertinent information available to abbott diabetes care has been submitted.This serves as a correction report.As per additional follow up with the customer, there was actually no medical event which occurred with this issue.Please disregard all reports associated with mdr 2954323-2022-38037.

• Brand Name: LIBRE 3 SENSOR FREESTYLE
• 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: 15609825
• MDR Text Key: 301812944
• Report Number: 2954323-2022-38037
• 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: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2022
• Device Model Number: 72081-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2022
• 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