MAUDE Adverse Event Report: Abbott Diabetes Care Ltd FreeStyle Libre 3; Continuous Glucose Monitoring System

Model Number	72079-01
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	09/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A missing low alarm issue was reported with the abbott diabetes care (adc) device.The low glucose alarms did not sound and the customer was not alerted of changes in glucose level.The customer experienced hypoglycemia, went to the emergency room (er), and received unspecified third-party treatment.It was indicated that the customer also had a high glucose reading "over 200."there was no report of death or permanent impairment associated with this event.
Additional Manufacturer Narrative
The product has been requested back for investigation and the customer agreed to return the device.A follow-up report will be submitted upon completion of investigation activities or if additional information is obtained.The date the incident occurred 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
• Common Device Name: Continuous Glucose Monitoring System
• Manufacturer (Section D): Abbott Diabetes Care Ltd; range road; witney 12345 -700; UK 12345-7001
• Manufacturer Contact: melissa pieplow ; 1360 south loop road; alameda, CA 94502--700 ; +1(510)384-5975
• MDR Report Key: 50797415
• Report Number: 2954323-2026-418762
• Device Sequence Number: 13142841
• Product Code: QBJ
• UDI-Device Identifier: 00357599820015
• UDI-Public: (01)00357599820015(10)01G295D
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/16/2026

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: 72079-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2025
• 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: Required Intervention
• Patient Sex: Unknown