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

Model Number 71992-01

Device Problems Device Alarm System (1012); Use of Device Problem (1670)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 06/30/2020

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The device manufacturing 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

A customer reported the low glucose alarm did not trigger with the freestyle libre 2 sensor.The customer subsequently lost consciousness and an emergency doctor was called.The customer was treated with glucose injection for diagnosis of hypoglycemia.It should be noted that during troubleshooting it was found that customer had not turned alarms on.There was no report of death or permanent injury associated with this event.

Event Description

A customer reported, the low glucose alarm did not trigger with the freestyle libre 2 sensor.The customer subsequently, lost consciousness and an emergency doctor was called.The customer was treated with glucose injection for diagnosis of hypoglycemia.It should be noted, that during troubleshooting, it was found that the customer had not turned alarms on.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 for the reader and sensor has not been provided.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.A tripped trend review was completed for the reported complaint, libre reader, and libre sensor, there were no adverse trends that indicate, any product-related issues.If the product is returned, the case will be re-opened, and a physical investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.

• 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: 11109252
• MDR Text Key: 224808401
• Report Number: 2954323-2021-00011
• 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: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• 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: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention