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

Model Number	71953-01
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported their adc device is too hot to hold.There was no report of fire, smoke, explosion, or shock.There was no report of death, serious injury, or mistreatment associated with this event.
Additional Manufacturer Narrative
At this time, investigation is pending.A follow-up report will be submitted upon completion of investigation activities.This complaint was reviewed and is being submitted as it has been reassessed as reportable as the result of retrospective review associated with a capa.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: 50922282
• Report Number: 2954323-2026-430043
• Device Sequence Number: 20333296
• Product Code: QLG
• UDI-Device Identifier: 00357599803001
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 71953-01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/21/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown