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 Abdominal Pain (1685); Chest Pain (1776); Hypoglycemia (1912); Loss of consciousness (2418); Shaking/Tremors (2515)

Event Date 11/01/2020

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.The dhrs (device history review) for the libre sensor and libre sensor kit were reviewed and the dhrs showed the libre sensor and 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.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A caregiver reported the customer's freestyle libre 2 sensor did not alarm for low glucose and because of this, the customer experienced tremors, gut and chest pain, and a loss of consciousness.Customer was treated with glucagon by the caregiver and was taken to a hospital where a reading of 28 mg/dl was obtained on the hcp meter.Customer was diagnosed with hypoglycemia and administered intravenous glucose, fluids, and food.There was no report of death or permanent injury associated with this event.

Event Description

A caregiver reported, the customer's freestyle libre 2 sensor did not alarm for low glucose.And because of this, the customer experienced tremors, gut and chest pain.And a loss of consciousness.Customer was treated with glucagon by the caregiver.And was taken to a hospital, where a reading of 28 mg/dl was obtained on the hcp meter.Customer was diagnosed with hypoglycemia.And administered intravenous glucose, fluids, and food.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 the low glucose alarm was successfully activated.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.Section g1: (contact office first name, contact office last name, contact office phone number and contact office email) has been updated.

• 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: 10820760
• MDR Text Key: 215883718
• Report Number: 2954323-2020-10325
• 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: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2021
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Date Manufacturer Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR
• Patient Weight: 20