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

Model Number 71992-01

Device Problem High Readings (2459)

Patient Problems Fall (1848); Hypoglycemia (1912); Loss of consciousness (2418); Convulsion/Seizure (4406)

Event Date 06/25/2022

Event Type  Injury  

Manufacturer Narrative

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.The reported product is not expected to be returned as reporter indicated the device was discarded.Therefore, no further investigations planned.In the event that unanticipated product is received, a physical investigation will be performed per adc's established processes and procedures and a follow-up report will be submitted upon completion of investigation.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported receiving high readings from the adc device.The customer experienced seizure, loss of consciousness, and fell down.The customer had contact with a healthcare professional who provided treatment of glucagon injection, ranja beverage, and pain relief for headache.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: 15032772
• MDR Text Key: 296009126
• Report Number: 2954323-2022-24394
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2023
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2022
• 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