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 Rash (2033); Skin Inflammation/ Irritation (4545)

Event Date 07/11/2022

Event Type  Injury  

Event Description

Abbott diabetes care received a medwatch report which reported the following information: a customer reported a skin reaction at the site of the adc device.The customer reported they had developed a rash, and went to dermatologist to have skin biopsy done.The customer was contacted and reported that on (b)(6) 2022, the customer went back to dermatologist and the skin biopsy was reported to have come back inconclusive.The customer was referred to allergist but has not scheduled appointment at time of contact.There was no report of additional treatment.The customer reported continued skin reactions with additional sensor wears, but there was no report of additional healthcare provider contact or treatment.The customer stated that since december 2022, they discontinued wear of sensors.Based on the information provided, there was no report of serious injury associated with this event.

Manufacturer Narrative

This complaint was received via user report and has been reported to fda.A follow-up report will be submitted once additional information is obtained.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.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.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.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.

Manufacturer Narrative

This complaint was received via user report and has been reported to fda.A follow-up report will be submitted once additional information is obtained.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.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.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.Clinical data was reviewed and confirmed that freestyle libre sensors continue to be safe, effective, and perform as intended in the field.A tripped trend review was conducted for the reported complaint and fs libre sensors, no trends were identified that would indicate any product related issues.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.This serves as a correction report.Section h-6 (type of investigation) codes and h-10 were incorrectly documented in the initial report.

Event Description

Abbott diabetes care received a medwatch report which reported the following information: a customer reported a skin reaction at the site of the adc device.The customer reported they had developed a rash, and went to dermatologist to have skin biopsy done.The customer was contacted and reported that on 11 jul 2022, the customer went back to dermatologist and the skin biopsy was reported to have come back inconclusive.The customer was referred to allergist but has not scheduled appointment at time of contact.There was no report of additional treatment.The customer reported continued skin reactions with additional sensor wears, but there was no report of additional healthcare provider contact or treatment.The customer stated that since december 2022, they discontinued wear of sensors.Based on the information provided, there was no report of serious 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: 16380762
• MDR Text Key: 309596667
• Report Number: 2954323-2023-06935
• Device Sequence Number: 1
• Product Code: QLG
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/13/2024

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: 06/30/2023
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/20/2023
• Initial Date FDA Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male