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

Model Number	78768-01
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A low readings issue was reported with the abbott diabetes care (adc) device.The customer received unspecified low readings on the adc device, and it is unknown whether the customer noted a trend arrow on the device.The customer called an ambulance and was hospitalized (duration unknown) due to low readings, but details of symptoms and treatment are unknown as the customer refused to provide additional information.There was no report of death or permanent injury associated with this event.
Additional Manufacturer Narrative
The reported product is not expected to be returned as the customer declined to return the device.A valid serial number has not been provided.An investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Clinical data was reviewed and confirmed that freestyle libre products continue to be safe, effective, and perform as intended in the field.Stability data for freestyle libre product was reviewed and showed no anomalies or non-conformances that could have led to the complaint.Tracking and trending reports for the past year were reviewed based on the product line and reported issue.The review identified a tripped trend, and an investigation was conducted, and corrective actions have been taken.The most probable root causes associated with this failure mode are disconnected, faulty or damaged components, software/data corruption, or misuse.However, mitigations are in place to reduce and prevent such issues.All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.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.No further investigation is planned.In the event that product is received, a physical investigation will be performed per adc's established processes and procedures, and a report will be submitted upon completion of investigation.The date of event is unknown.The date entered in section b3 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 PLUS
• Common Device Name: CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: patricia reis castro ; 1360 south loop road; alameda, CA 94502-7001 ; 4157205405
• MDR Report Key: 24737975
• Report Number: 2954323-2026-19141
• Device Sequence Number: 8869170
• Product Code: QBJ
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K223435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 78768-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown