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

Model Number 71953-01

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2021

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 the product is returned, a physical investigation will be performed and a follow-up report submitted.The device manufacturing date is unknown.The date entered is the date abbott diabetes care became aware of the event.An additional reader 2 (serial numbers unknown) has been captured under this submission.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Abbott diabetes care received a medwatch user report which reported the following information: a customer reported 2 issues he has with the freestyle libre 2 reader settings.The customer stated that the "turning reader off" message displayed when using physical button on the reader is misleading, and leads the customer to believe that the reader will no longer communicate with sensor, instead of locking the touchscreen.As a result, the customer has left the reader "on", but by putting the reader in the pocket in this state, the touchscreen has inadvertently made changes to the settings.Due to this, the customer reported issues with glucose values being recorded under wrong date (date settings changed) and alarm sound being lowered, leading to possible missed alerts.The customer suggested clearer wording when turning touchscreen off, additional information added to device manual, and the ability to correct glucose data if incorrectly recorded.There was no report of any third-party medical intervention due to reported issues and no further details were provided.Based on the information provided, there was no report of serious 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
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 11634972
• MDR Text Key: 244445553
• Report Number: 2954323-2021-65935
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193371
• 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: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71953-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1