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 Problems Pain (1994); Skin Irritation (2076)

Event Date 09/22/2020

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 discomfort/pain/bruising, 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.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 experiencing a skin reaction while wearing the adc freestyle libre 2 sensor, with a symptom of pain and purple at the sensor insertion site.The customer had contact with a healthcare provider who removed the sensor and applied betadine (disinfectant) and prescribed an unspecified ointment as treatment.There was no report of death or permanent injury associated with this event.

Event Description

A customer experiencing a skin reaction while wearing the adc freestyle libre 2 sensor, with a symptom of pain and purple at the sensor insertion site.The customer had contact with a healthcare provider who removed the sensor and applied betadine (disinfectant) and prescribed an unspecified ointment as treatment.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Section d3 (email) and section g1 were updated to reflect current contact information.Sensor ((b)(6)) has been returned and investigated.Visual inspection was performed on the returned sensor and adhesive and no issues were observed.The sensor plug was properly seated in the mount.The sensor plug was removed and the plug assembly was inspected, no issues observed.Further investigation was unable to be performed, as the applicator and and pack were not returned.No malfunction or product deficiency was identified.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
• MDR Report Key: 10600429
• MDR Text Key: 208974685
• Report Number: 2954323-2020-06656
• 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: 02/16/2021

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: 10/31/2021
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 09/29/2020
• Supplement Dates Manufacturer Received: 01/26/2021
• Supplement Dates FDA Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 94