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 Hypersensitivity/Allergic reaction (1907); Skin Inflammation/ Irritation (4545)

Event Date 02/26/2024

Event Type  Injury  

Manufacturer Narrative

Sensor (b)(6)has been returned and is currently undergoing investigation process.A follow up report will be submitted once all investigation activities are complete.The date the incident occurred is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.The device manufacturing date is unknown.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.

Event Description

An adverse skin reaction was reported with wear of the adc device.Customer experienced "allergic reaction" at the sensor site and had contact with a healthcare professional who prescribed flixonase (fluticasone propionate) nasal spray for treatment.There was no report of death or permanent impairment associated with this event.

Event Description

An adverse skin reaction was reported with wear of the adc device.Customer experienced "allergic reaction" at the sensor site and had contact with a healthcare professional who prescribed flixonase (fluticasone propionate) nasal spray for treatment.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Sensor (b)(6)was returned and investigated.Visual inspection was performed, and no issues were observed.Visual inspection was performed on the returned adhesive and no issues were observed.No malfunction or product deficiency was identified.This issue is not confirmed.An extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specification.The reported complaint is related to skin irritation or an allergic reaction to the patch adhesive of the freestyle libre sensor.Dose audit reports were reviewed and demonstrates the continued effectiveness of the established sterilization process for libre sensor products.Environmental monitoring reports were reviewed, including bioburden and endotoxin testing, and demonstrated that all monitoring processes continue to meet adc minimum requirements for product quality.Dhrs (device history review) for the freestyle libre sensor kit were reviewed and the dhrs(device history review) showed the freestyle libre sensor kit passed all tests prior to release.All pertinent information available to abbott diabetes care has been submitted.

• 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: 18975998
• MDR Text Key: 338547001
• Report Number: 2954323-2024-09928
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 05021791001316
• UDI-Public: (01)05021791001316(17)2024-06-30(10)KTP006148(91)72002-01
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• 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
• Date Returned to Manufacturer: 03/14/2024
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2023
• 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