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

Model Number	71953-01
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Codes	Hypoglycemia (1912); Nausea (1970)
Date of Event	08/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer reported an unexpected low glucose alarm with the abbott diabetes care (adc) device.As a result, the customer experienced symptoms described as a lack of sleep and nausea.Due to the continuous unexpected low glucose alarms, the customer self-treated by consuming candy.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.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FreeStyle Libre 2
• Common Device Name: Flash 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: 50871370
• Report Number: 2954323-2026-427647
• Device Sequence Number: 9379787
• Product Code: QLG
• UDI-Device Identifier: 00357599803001
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K193371
• 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): 09/23/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 71953-01
• 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: 08/20/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/28/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Other
• Patient Sex: Unknown