MAUDE Adverse Event Report: ABBOTT DIABETES CARE LTD FREESTYLE LIBRE 3; CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number 72075-01

Device Problems Unable to Obtain Readings (1516); Application Program Problem (2880)

Patient Problems Hypoglycemia (1912); Nausea (1970); Blurred Vision (2137); Loss of consciousness (2418); Convulsion/Seizure (4406)

Event Date 02/24/2024

Event Type  Injury  

Manufacturer Narrative

Extended investigation is pending at this time.A follow up will be submitted once additional information is obtained.The device manufacturing date does not apply.The date entered in section h4 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 contacted abbott diabetes care (adc) customer services as "they needed assistance to set up the freestyle libre 3 app".During the call, the customer indication they "did know how to set up the freestyle libre 3 application and was unable to navigate their phone" during troubleshooting.The customer further reported experiencing a medical event as they were unable to monitor their glucose since they didn't know how to set up the freestyle libre app by themselves.The customer experienced symptoms nausea, tingling of limbs, loss of vision, a seizure, and a loss of consciousness.The ambulance was called and upon arriving, the customer was provided tablets for a diagnosis of hypoglycemia.No further information was provided.There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE LIBRE 3
• Type of Device: CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE LTD; range road; witney 12345 -700; UK 12345-7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 18946919
• MDR Text Key: 338184633
• Report Number: 2954323-2024-09430
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213996
• 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: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 72075-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/28/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention