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); Chills (2191); Loss of consciousness (2418)

Event Date 10/17/2021

Event Type  Injury  

Manufacturer Narrative

Sensor (b)(4) has been returned and investigated.The sensor plug was properly seated, and no 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.A linearity test was performed, and the results were within specification.No malfunction or product deficiency was identified.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs (device history record) 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.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.The customer obtained a sensor scan of 160 mg/dl compared to a fingerstick reading of "500+" on an unspecified meter and experienced symptoms of pain, chills, fatigue, and loss of consciousness.The customer's healthcare provider arrived at her home and administered insulin (dose/type unknown) for treatment of hyperglycemia and was provided with unspecified antibiotics for infected abscess.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: 12790935
• MDR Text Key: 280678553
• Report Number: 2954323-2021-91997
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599800000
• UDI-Public: 00357599800000
• 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: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2022
• Device Model Number: 71992-01
• Device Catalogue Number: 71992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Date Manufacturer Received: 10/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female