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 Bruise/Contusion (1754); Hemorrhage/Bleeding (1888)

Event Date 10/04/2020

Event Type  Injury  

Manufacturer Narrative

The reported product is not expected to be returned as the customer discarded the product.A follow-up report will be filed if product is returned or additional information is obtained.The exact date that the incident occurred is unknown.The date entered is based on the customer report of "3 months ago".The device mfg date is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

The customer reported experiencing bleeding and a bruise after inserting the adc freestyle libre 2 sensor and received unspecified third-party treatment.No further information was provided.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

No product has been returned.And a valid serial number has not been provided.An extended investigation has been performed for the reported complaint, and there was no indication that the product did not meet specification.A clinical review has been conducted, and the review has found no indication of any product clinical performance issues.A tripped trend review was conducted for the reported complaint and libre sensor, no trends were identified that would indicate any product related issues.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.Additional information - section g1: (contact office first name, contact office last name, contact office phone number and contact office email) has been updated.

Event Description

The customer reported, experiencing bleeding and a bruise after inserting the adc freestyle libre 2 sensor.And received unspecified third-party treatment.No further information was provided.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: 11189630
• MDR Text Key: 227508166
• Report Number: 2954323-2021-01379
• 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: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 72