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); Itching Sensation (1943); Rash (2033)

Event Date 02/23/2023

Event Type  Injury  

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 there was no indication that the product did not meet specification.The device history records (dhrs) for the freestyle libre sensor kit were reviewed and the dhrs showed the freestyle 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 adc device and experienced itchy insertion area and rash at the sensor site.Customer had contact with a healthcare professional and was prescribed ¿topical tto¿ for treatment.There was no report of death or permanent injury 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.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer experienced a skin reaction while wearing an adc device and experienced itchy insertion area and rash at the sensor site.Customer had contact with a healthcare professional and was prescribed ¿topical tto¿ for treatment.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

An extended investigation has been performed for the reported complaint and 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 product.Dose audit reports were reviewed and demonstrates the continued effectiveness of the established sterilization process for libre sensor kits.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 review) for the libre sensor kits were reviewed and the dhrs showed the libre sensor kits passed all tests prior to release.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.This serves as a correction report.Section h10 (addtl mfg narrative) was incorrectly documented in the initial report.Correction has been made.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer experienced a skin reaction while wearing an adc device and experienced itchy insertion area and rash at the sensor site.Customer had contact with a healthcare professional and was prescribed ¿topical tto¿ for treatment.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: 16501984
• MDR Text Key: 310869977
• Report Number: 2954323-2023-09394
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2024
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2022
• 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