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 Problem Bruise/Contusion (1754)

Event Date 01/14/2021

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.Dhrs (device history record) 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.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 reported bruising at the site of the freestyle libre 2 sensor.The customer reported receiving third-party treatment from healthcare professional due to bruising; however, no further information was provided.Thus far, attempts to reach customer to obtain additional information have been unsuccessful.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

This follow up report is to provide the following additional information: abbott diabetes care was able to reach customer on (b)(6)2021.The customer was able to confirm that no medical treatment was necessary for reported product issue.Based on the additional information provided, there is no indication that the adc device was involved in or contributed to the reported medical event; therefore, adc considers this issue closed.All pertinent information available to abbott diabetes care has been submitted.This serves as a correction report: h10 addtl mfg narrative has been updated to provide additional information, upon follow-up with customer.H6 health effect - impact code was updated to reflect new information.

Event Description

A customer reported bruising at the site of the freestyle libre 2 sensor.The customer reported receiving third-party treatment from healthcare professional due to bruising; however, no further information was provided.Thus far, attempts to reach customer to obtain additional information have been unsuccessful.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
• MDR Report Key: 11312156
• MDR Text Key: 231305923
• Report Number: 2954323-2021-03685
• 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: 03/12/2021

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: 12/31/2021
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/11/2021
• Supplement Dates Manufacturer Received: 02/15/2021
• Supplement Dates FDA Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 102