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

Model Number 72077-01

Device Problems Device Alarm System (1012); Application Program Problem (2880)

Patient Problem Hypoglycemia (1912)

Event Date 01/07/2024

Event Type  Injury  

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 high/low glucose alarms with freestyle libre 3 application.Adc attempted to replicate the reported issue using similar configuration of iphone 12, os 16.6.1, and application version 3.5.0.8863.Per the abbott diabetes care compatibility guide for the freestyle libre 3 app, the reported configuration of the ios 16.6.1 is not compatible with the freestyle libre 3 app.The latest revision of the compatibility guide is available to the customer on the abbott diabetes care website.As the compatibility guide is provided to the customer and the incompatible configurations were used, this complaint is not confirmed to use.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

An alarm issue was reported with the adc device in use with an iphone 12 with ios operating system version 16.6.1.The low and high glucose alarms did not sound and customer was not alerted of changes in glucose level.As a result, the customer experienced hypoglycemia with symptoms described as "paralysis, freezing cold," and was unable to self-treat, requiring non-hcp third-party administration of honey for treatment.No further treatment was indicated.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: 19004419
• MDR Text Key: 338916072
• Report Number: 2954323-2024-10497
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599817008
• UDI-Public: 00357599817008
• 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
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 72077-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2024
• 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
• Patient Age: 50 YR
• Patient Sex: Female