MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71992-01

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Skin Irritation (2076)

Event Date 11/23/2020

Event Type  Injury  

Manufacturer Narrative

At this time product has not yet been returned.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 demonstrated 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.Clinical data was reviewed and confirmed that freestyle libre sensor continue to be safe, effective, and perform as intended in the field.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 reported experiencing a skin reaction during the adc freestyle libre 2 sensor wear.The customer experienced insertion site allergy and had contact with a healthcare professional and received unspecified treatment.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Sensor ((b)(6)) has been returned and investigated.Visual inspection was performed on the returned sensor patch and no issues were observed.The sensor adhesive was not returned.No malfunction or product deficiency was identified.An extended investigation has also been performed for the reported complaint based on the returned product serial number.Dhrs (device history record) for the libre sensor kit were reviewed and the dhrs showed the libre sensor kit passed all tests prior to release.Section d3 (email) and section g1 have been updated to reflect current contact information.Section d4 (serial number) has been updated from (b)(6) to (b)(6) based on the returned product.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported experiencing a skin reaction during the adc freestyle libre 2 sensor wear.The customer experienced insertion site allergy and had contact with a healthcare professional and received unspecified treatment.There was no report of death or permanent impairment 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
• MDR Report Key: 10929352
• MDR Text Key: 219128219
• Report Number: 2954323-2020-12419
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• PMA/PMN Number: K193371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2021
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Date Manufacturer Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR