MAUDE Adverse Event Report: Abbott Diabetes Care Inc FreeStyle Libre 2 Plus; Continuous Glucose Monitoring System

Model Number	78747-01
Medical Device Problem Codes	Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	08/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An unspecified sensor error message was reported with the abbott diabetes care (adc) device and customer was unable to obtain readings.The customer did not report any symptoms but an ambulance was called.Upon arrival, a glucose reading of 32 mg/dl was obtained on unknown device.The ambulance staff attempted intravenous insertion multiple times; the customer resisted, fell from chair, but recovered after oral glucose medication within 5-10 minutes.There was no report of death or permanent impairment 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 follow-up report will be submitted upon completion of investigation activities or if additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FreeStyle Libre 2 Plus
• Common Device Name: Continuous Glucose Monitoring System
• Manufacturer (Section D): Abbott Diabetes Care Inc; 1360 south loop road; alameda CA 94502 -700
• Manufacturer Contact: melissa pieplow ; 1360 south loop road; alameda, CA 94502--700 ; +1(510)384-5975
• MDR Report Key: 50927102
• Report Number: 2954323-2026-430156
• Device Sequence Number: 10735208
• Product Code: QBJ
• UDI-Device Identifier: 00357599835019
• UDI-Public: (01)00357599835019(17)2026-10-31(10)KTP015176(91)78747-01D
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/28/2026

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: 78747-01
• 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: 08/29/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Male