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

Model Number 72077-01

Device Problems Unable to Obtain Readings (1516); Component or Accessory Incompatibility (2897)

Patient Problem Insufficient Information (4580)

Event Date 06/05/2023

Event Type  Injury  

Manufacturer Narrative

Extended investigation is pending at this time.A follow up will be submitted once additional information is obtained.The date of event is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.The device manufacturing date is unknown.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

Customer reported the iphone 6 is not compatible with the libre 3 app.As a result, customer received unspecified treatment from a healthcare professional.No further details were provided.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Smartphone compatibility with the use of freestyle libre 3 and the iphone 6 device has not been tested at the time of the investigation.The compatibility guide states that abbott diabetes care has not assessed compatibility on phone/operating systems other than those listed.This guide is available to the user on the websites where the product is launched.The freestyle libre 3 complaint was investigated and determined that there were no issues with the libre 2 application that would have led to the complaint.The user reported an unspecified treatment when scanning the sensor with the freestyle libre 3 application resulting in the customer being unable to monitor glucose with sensor readings.Attempted to replicate the user complaint on a iphone 13 mini using a known good libre 2 sensor and successfully receive high/low glucose alarms the users complaint couldn't be identified with the freestyle libre 3 app.Thus, this complaint is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Customer reported the iphone 6 is not compatible with the libre 3 app.As a result, customer received unspecified treatment from a healthcare professional.No further details were 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: 17263768
• MDR Text Key: 318440257
• Report Number: 2954323-2023-28845
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212132
• 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: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 72077-01
• Device Catalogue Number: 72077-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2023
• 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