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

Model Number 71992-01

Device Problem No Audible Alarm (1019)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418); Sweating (2444)

Event Date 12/06/2020

Event Type  Injury  

Manufacturer Narrative

Abbot diabetes care product quality engineering (pqe) investigated the alarm-3 (missing high or low glucose ) complaint.The serial number of the freestyle libre 2 sensor associated with this complaint is unknown.During investigation of the track and trend review related to alarm-3 cases in (b)(6) 2020 this failure mode was identified and is a known manufacturing issue that impacts libre 2 sensors manufactured at flex buffalo grove (fbg).As the serial number of the sensor associated with this complaint is unknown, pqe is unable to determine if the sensor is impacted by this manufacturing issue.Outside of the known manufacturing issue, the available tripped trend reports for libre 2 sensor and alarm-3 have been reviewed.The review did not identify any additional trends that would indicate a product related issue related to this complaint.If the product is returned, the case will be re-opened, and a physical investigation will be performed.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 missing the low glucose alarm while wearing the adc freestyle libre 2 sensor.On (b)(6) 2020, as a result, the customer experienced cold sweats and lost consciousness.The customer was treated with an injection of glucagon by the customer's partner.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: erica frank ; 1360 south loop road; alameda, CA 94502-7001 ; 5104242454
• MDR Report Key: 11041097
• MDR Text Key: 222619327
• Report Number: 2954323-2020-14031
• 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
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Weight: 90