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 Erythema (1840); Hypersensitivity/Allergic reaction (1907); Pain (1994); Skin Inflammation/ Irritation (4545)

Event Date 05/25/2023

Event Type  Injury  

Event Description

A customer experienced a skin reaction while wearing an abbott diabetes care (adc) device and experienced "pain, red skin, and inflamed" at the sensor site.Customer had contact with a healthcare professional received third-party treatment of cortisone cream.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

The product has been requested back for an investigation.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 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.The device history records (dhrs) for the fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor kit passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer experienced a skin reaction while wearing an abbott diabetes care (adc) device and experienced "pain, red skin, and inflamed" at the sensor site.Customer had contact with a healthcare professional received third-party treatment of cortisone cream.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 has been performed on the returned sensor and no damage were observed.Inspected the plug assembly; observed sharp stuck inside plug assembly.No issues were observed with the adhesive.Issue is not confirmed.Extended investigation has been performed for the updated serial number and reported complaint and there was no indication that the product did not meet specification.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.The dhrs (device history record) for the freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor kit passed all tests prior to release.Section d4 (serial number) was updated from (b)(6) based on returned product download.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 CA 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 17085138
• MDR Text Key: 316745815
• Report Number: 2954323-2023-24083
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 09/15/2023

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: 05/31/2024
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 05/31/2023
• Initial Date FDA Received: 06/08/2023
• Supplement Dates Manufacturer Received: 08/29/2023
• Supplement Dates FDA Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2023
• 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