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

Model Number 71992-01

Device Problem Device Alarm System (1012)

Patient Problems Hypoglycemia (1912); Seizures (2063)

Event Date 11/20/2020

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 mfg 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 their adc freestyle libre 2 sensor did not alarm when glucose was low.The customer experienced seizure and self-treated with cola.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

No product has been returned and an extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specifications.Dhrs (device history review) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor and freestyle libre 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.

Event Description

A customer reported their adc freestyle libre 2 sensor did not alarm when glucose was low.The customer experienced seizure and self-treated with cola.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.The sensor plug was properly seated, and no physical damage was observed on the sensor patch.Extracted data from the returned sensor using approved software.Sensor found to be in state 5 (indicating normal termination).Performed visual inspection of the sensor plug assembly and no failure modes were observed.Linearity test was performed, and results were within specification.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.Additional information - section g1: (contact office first name, contact office last name, contact office phone number and contact office email) has been updated.Section h4 (device mfg date) was updated based on returned product download.

Event Description

A customer reported their adc freestyle libre 2 sensor did not alarm when glucose was low.The customer experienced seizure and self-treated with cola.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
• MDR Report Key: 10920582
• MDR Text Key: 218717146
• Report Number: 2954323-2020-12254
• 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,Followup
• Report Date: 03/03/2021

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: 12/31/2021
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 11/30/2020
• Supplement Dates Manufacturer Received: 12/03/2020; 02/05/2021
• Supplement Dates FDA Received: 12/16/2020; 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1