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

Model Number 72075-01

Device Problem Device Alarm System (1012)

Patient Problems Hypoglycemia (1912); Dizziness (2194)

Event Date 04/08/2024

Event Type  Injury  

Event Description

An alarm issue was reported with the abbott diabetes care (adc) device while using the mobile device, samsung z flipp 4, with an android operating system version 14.The customer indicated that the low glucose alarms did not sound, and therefore, the customer was not alerted to changes in glucose level and therefore was unable to manage their blood glucose treatments.As a result, the customer ¿did not feel good¿ and experienced dizziness was unable to provide self- treatment due to their symptoms.The customer was provided with oral sugar water as treatment from a non-healthcare professional (non-hcp).There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

The most probable root causes associated with this failure mode are software/data corruption or misuse.However, mitigations are in place to reduce and prevent such issues.All vital functions are monitored by the system and, when necessary, function is suspended to safeguard against inaccurate results.Labeling is provided to instruct the user on the intended use of all vital parts of the system to minimize misuse.All complaints and complaint trends are investigated to determine if there is a product defect/ deficiency.If a product defect/ deficiency is identified, a risk evaluation is completed and compared to the risk management report, to ensure the risk profile has not changed.Additionally, as a part of abbott¿s post-market surveillance process, all risk evaluations with associated complaint data are reviewed annually to determine if the risk profiles have changed as compared to the product risk management reports.These monitoring processes ensure that all product risk profiles remain acceptable and have a positive benefit/ risk ratio.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The customer experienced missing low glucose alarms with freestyle libre 3 application.Abbott diabetes care (adc) attempted to replicate the reported issue using similar configuration of samsung z flipp 4 with android operating system version 14.The reported issue was unable to be replicated as the reported configuration of [android 14] is not compatible with freestyle libre 3 app and the system functioned as intended.There were no issue identified with the freestyle libre 3 app during replication that would have led to the reported issue.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.

• 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 94502-7001 ; 5107495297
• MDR Report Key: 19161021
• MDR Text Key: 340790211
• Report Number: 2954323-2024-13752
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• 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: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2024
• 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