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

Model Number 71940-01

Device Problems Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burning Sensation (2146); Skin Inflammation/ Irritation (4545)

Event Date 01/07/2022

Event Type  Injury  

Manufacturer Narrative

This is an initial final report. this issue does not meet reportability criteria; however, it is being reported to the fda as the complaint was received via user report.If product is returned, this case will be re-opened, an investigation will be conducted, and a follow-up report will be submitted after all investigation activities are complete.The device manufacturing date is unknown.The date entered in is the date abbott diabetes care became aware of the event.2 sensors (unknown, unknown) were reported in the user report and both have been captured in this mdr.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Abbott diabetes care received a medwatch report which reported the following information: a customer reported on issues with 2 of adc devices.The customer reported experiencing a skin reaction while wearing one of the sensors and experienced symptoms described as ¿skin tear¿ and a burning sensation after sensor removal.The second sensor encountered a ¿replace sensor¿ error message on the 3rd day of use and due to the error message, the sensor did not work.No further details were reported and there was no report of an adverse event or third-party treatment due to the reported issues.Based on the information provided, there was no report of serious injury associated with this event.

• 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
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 13620741
• MDR Text Key: 286256154
• Report Number: 2954323-2022-06715
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71940-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male