MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 14 DAY; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71940-01

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Skin Irritation (2076); Burning Sensation (2146)

Event Date 10/21/2020

Event Type  Injury  

Manufacturer Narrative

Gt hold 11 10 sensor (b)(4) has been returned and investigated.The sensor plug was properly seated, and no physical damage was observed on the sensor patch.No failure modes were observed on the sensor plug assembly upon visual inspection.No issues were observed with the adhesive.No malfunction or product deficiency was identified.An extended investigation has also 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.Dhrs (device history review) 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.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported a skin reaction at the site of the freestyle libre sensor, with symptoms of irritation, burning sensation, and pain.The customer had contact with a healthcare professional, and received unspecified treatment.There was no report of death or permanent injury associated with this event.

Event Description

A customer reported a skin reaction at the site of the freestyle libre sensor, with symptoms of irritation, burning sensation, and pain.The customer had contact with a healthcare professional, and received unspecified treatment.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

This is a correction for section h10 as the dhr information was incorrectly documented.H10 has been updated to add the dhr's for the sensor as well.Dhrs (device history review) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor and freestyle libre sensor kit passed all tests prior to release.

• Brand Name: FREESTYLE LIBRE 14 DAY
• Type of Device: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• MDR Report Key: 10823956
• MDR Text Key: 215887871
• Report Number: 2954323-2020-10438
• Device Sequence Number: 1
• Product Code: PZE
• UDI-Device Identifier: 00357599001018
• UDI-Public: 00357599001018
• Combination Product (y/n): N
• PMA/PMN Number: P160030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 11/30/2020

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: 10/31/2020
• Device Model Number: 71940-01
• Device Catalogue Number: 71940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 11/11/2020
• Supplement Dates FDA Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 54