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	02/22/2024
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
The reader was returned and visual inspection has been performed since the reader had been de-cased prior to assessment.This issue is unable to be tested due to the product not being in a condition that allows the re-testing of the product to reproduce or verify the customer¿s complaint.However, the reader no longer turns on and battery was observed to be swollen.This is unable to test.At the time of complaint intake, this event was deemed not reportable and troubleshooting determined that no further investigation of the device was required.This complaint has been reassessed as reportable upon retrospective review associated with a capa and is being submitted with all available information.Section h6 (investigation findings) code c20 (no findings available) and d15 cause not established was selected, as adc was unable to perform further testing on the returned device.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: 50857636
• Report Number: 2954323-2026-426811
• Device Sequence Number: 21345569
• Product Code: QLG
• UDI-Device Identifier: 00357599803001
• Combination Product (Y/N): N
• 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): 09/22/2026

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: 07/10/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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