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

Model Number 71953-01

Device Problem Use of Device Problem (1670)

Patient Problem Hypoglycemia (1912)

Event Date 05/26/2021

Event Type  Injury  

Manufacturer Narrative

At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.Dhrs (device history record) for the libre reader were reviewed and the dhrs showed the libre reader passed all tests prior to release.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 that the language setting of the freestyle libre 2 reader was set to (b)(6), and was therefore unable to use the reader as she could not understand the language.As a result, the customer was unable to monitor glucose, experienced unspecified symptoms of hypoglycemia, and called for an ambulance.Upon their arrival, the customer was provided with unspecified medication to raise glucose levels.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
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 11983155
• MDR Text Key: 255631499
• Report Number: 2954323-2021-72155
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599804008
• UDI-Public: 00357599804008
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71953-01
• Device Catalogue Number: 71952
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention