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

Model Number 71953-01

Device Problem Use of Device Problem (1670)

Patient Problem Loss of consciousness (2418)

Event Date 08/24/2021

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 reader were reviewed and the dhrs showed the libre reader kits passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The date of event 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 customer reported missing data in the memory of the adc freestyle libre 2 reader.As a result, the customer had a loss of consciousness.No further information was provided as the customer declined to continues the troubleshooting process.There was no report of death or permanent injury.

Event Description

A customer reported missing data in the memory of the adc freestyle libre 2 reader.As a result, the customer had a loss of consciousness.No further information was provided as the customer declined to continues the troubleshooting process.There was no report of death or permanent injury.

Manufacturer Narrative

Reader mcga319-j6939 has been returned and investigated.Visual inspection has been performed on the returned reader and no issues were observed.Missing graph was observed upon data analysis due to data quality (dq) errors.These gaps were due to the fact that some data uploaded from the sensor did not meet the data quality criteria and therefore was not displayed to the user.Sensor data may be changing too fast, have too much noise, or be too low or too high.The issue observed could not have caused the customer's complaint.The reader was functioning as intended.The issue is not confirmed.Additional information: a tripped trend review was conducted for the reported complaint and fs libre sensor and there were no adverse trends that indicate any product-related issues.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
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 12413873
• MDR Text Key: 269532385
• Report Number: 2954323-2021-82846
• Device Sequence Number: 1
• Product Code: QLG
• 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,Followup
• Report Date: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71953-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Date Manufacturer Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female