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

Model Number 71992-01

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

Patient Problems Purulent Discharge (1812); Skin Infection (4544); Swelling/ Edema (4577)

Event Date 01/02/2024

Event Type  Injury  

Manufacturer Narrative

Sensor (b)(6) was returned and a follow-up report will be submitted once additional information is obtained.The date the incident occurred is unknown.The date entered in section b3 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 adverse skin reaction was reported while wearing the adc device.The customer experienced a skin infection, swelling, had puss at sensor site.As a result, had contact with a healthcare professional (doctor) who provided an unspecified antibiotic as treatment for this issue.There was no report of death or permanent injury 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 CA 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 18619611
• MDR Text Key: 334255646
• Report Number: 2954323-2024-03910
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599800000
• UDI-Public: 00357599800000
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 01/31/2024

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 Expiration Date: 03/31/2024
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2024
• Initial Date Manufacturer Received: 01/02/2024
• Initial Date FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/03/2023
• 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
• Patient Sex: Male