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

Model Number 71992-01

Device Problem Low Readings (2460)

Patient Problems Fatigue (1849); Hyperglycemia (1905); Polydipsia (2604); Balance Problems (4401)

Event Date 08/17/2021

Event Type  Injury  

Manufacturer Narrative

The customer¿s product has been requested for investigation.A follow-up report will be filed once additional information is obtained.The device manufacturing date is unknown.The date entered in 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 low reading issue was reported with the freestyle libre 2 sensor.A customer reported receiving lower sensor scans compared to readings obtained on the built-in meter.The customer experienced symptoms of thirst, tiredness, tingling legs, was unable to walk, and "blindness" on the way to the hospital.Customer was diagnosed with hyperglycemia and received unspecified infusion.There was no report of death or permanent injury associated with this event.

Event Description

A low reading issue was reported with the freestyle libre 2 sensor.A customer reported receiving lower sensor scans compared to readings obtained on the built-in meter.The customer experienced symptoms of thirst, tiredness, tingling legs, was unable to walk, and "blindness" on the way to the hospital.Customer was diagnosed with hyperglycemia and received unspecified infusion.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

No product has been returned.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and sensor kit 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.

• 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: 12447730
• MDR Text Key: 270574599
• Report Number: 2954323-2021-83769
• 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: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2022
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/31/2021
• Initial Date FDA Received: 09/09/2021
• Supplement Dates Manufacturer Received: 09/10/2021
• Supplement Dates FDA Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention