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

Event Date 06/27/2022

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.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

An alarming issue was reported with the adc device.A customer reported that while using the freestyle libre 2 app, the sensor alarm failed to trigger when the customer¿s glucose was low.As a result, the customer experienced a seizure, loss of consciousness, and fell out of bed.The customer was unable to self-treat and was treated with lemon fanta by the wife and no further information was reported.There was no report of death or permanent injury associated with this event.

Event Description

An alarming issue was reported with the adc device.A customer reported that while using the freestyle libre 2 app, the sensor alarm failed to trigger when the customer¿s glucose was low.As a result, the customer experienced a seizure, loss of consciousness, and fell out of bed.The customer was unable to self-treat and was treated with lemon fanta by the wife and no further information was reported.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specification.The dhrs (device history review) for the libre sensor and libre sensor kits were reviewed and the dhrs showed the libre sensor and libre sensor kits passed all tests prior to release.A known good fs libre 2 sensor was used with the librelink app and both high and low glucose alarms were successfully received.No issues were identified with the librelink app.If the product is returned, the case will be re-opened, and a physical investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.This serves as a correction report as the initial mdr report inadvertently was missing the extended investigation on the reported sensor.H6 adverse event problem and h10 - addtl mfg narrative have been updated to include extended investigation findings.

• 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: 15003709
• MDR Text Key: 295812029
• Report Number: 2954323-2022-23859
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• 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: 01/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2022
• 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