MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 14 DAY; FLASH GLUCOSE MONITORING SYSTEM

Model Number	71938-01
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physical investigation of product is not anticipated as reporter indicated device was discarded.Investigation will be performed per adc's established processes and procedures, and a report will be submitted upon completion of investigation activities.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
Customer reports their abbott diabetes care device was too hot to hold while carrying it in their pocket.Customer further reports their device, "caught fire" and "left mild burns on his hand." there was no report of smoke, explosion, or shock.There was no report of death, serious injury, or mistreatment associated with this event.
Additional Manufacturer Narrative
Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.The most probable root causes associated with this failure mode are disconnected, faulty or damaged components or misuse.However, mitigations are in place to reduce and prevent such issues.All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.Labeling is provided to instruct the user on the intended use of all vital parts of the system to minimize misuse.All complaints and complaint trends are investigated to determine if there is a product defect/ deficiency.If a product defect/ deficiency is identified, a risk evaluation is completed and compared to the risk management report, to ensure the risk profile has not changed.Additionally, as a part of abbott¿s post-market surveillance process, all risk evaluations with associated complaint data are reviewed annually to determine if the risk profiles have changed as compared to the product risk management reports.These monitoring processes ensure that all product risk profiles remain acceptable and have a positive benefit/ risk ratio.At this time, the product has not yet been returned for this complaint.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The dhrs (device history review) for the libre reader, cable and adapter was reviewed and the dhrs showed the products met specifications prior to release to distribution.The reported product is not expected to be returned as reporter indicated the device was discarded.Therefore, no further investigation is planned.In the event that product is received, a physical investigation will be performed per adc's established processes and procedures and a report will be submitted upon completion of investigation.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
Customer reports their abbott diabetes care device was too hot to hold while carrying it in their pocket.Customer further reports their device, "caught fire" and "left mild burns on his hand." there was no report of smoke, explosion, or shock.There was no report of death, serious injury, or mistreatment associated with this event.

• Brand Name: FREESTYLE LIBRE 14 DAY
• Common Device Name: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 21306745
• Report Number: 2954323-2025-04247
• Device Sequence Number: 8849187
• Product Code: PZE
• UDI-Device Identifier: 00357599002008
• UDI-Public: (01)00357599002008(10)04C160D
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P160030
• 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,Followup
• Report Date (Section B): 02/07/2025

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: 71938-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2025
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2022
• 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 Age: 37 YR
• Patient Sex: Male