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	12/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports observing visible smoke from their abbott diabetes care device.The customer further details smoke appearing from the reader when it was put to charge.There was no report of fire, explosion, or shock.There was no report of death, serious injury, or mistreatment associated with this event.
Additional Manufacturer Narrative
Product has been returned and is currently undergoing investigation process.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.
Event or Problem Description
The customer reports observing visible smoke from their abbott diabetes care device.The customer further details smoke appearing from the reader when it was put to charge.There was no report of fire, explosion, or shock.There was no report of death, serious injury, or mistreatment associated with this event.
Additional Manufacturer Narrative
Reader (b)(6) has been returned and investigated.Visual inspection has been performed on the returned reader and liquid contamination was observed on the usb port.It was observed that reader's usb port was not functioning as intended due to liquid contamination.The customer returned usb charger and usb cable with the reader.Visual inspection has been performed on the returned the cable and liquid contamination was observed.Visual inspection has been performed on the returned power adapter and no issues were observed.Performed load test on the power adapter and results were within specification range.No evidence of visible smoke was observed.It was observed that reader does not powered on, therefore, unable to perform built in reader test.The returned reader was further investigated and de-cased.Visual inspection has been performed on the de-cased reader's pcba (printed circuit board assembly) and no signs of damage or burn marks were observed.Liquid contamination was observed on the pcba of the returned reader.The returned battery voltage was measured and it was not within specification range.Unable to monitor reader under thermal camera during operation due to reader not powering on.Unable to perform power consumption test due to liquid contamination on pcba.The observed liquid contamination observed is the result of foreign ingress introduced to the pcba while in the hands of the customer.This contamination is not an indication of a product failure and is the result of misuse.Therefore, this issue is not confirmed to use due to liquid contamination.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.All pertinent information available to abbott diabetes care has been submitted.

• 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: 20981675
• Report Number: 2954323-2024-49459
• Device Sequence Number: 12809807
• Product Code: PZE
• UDI-Device Identifier: 00357599002008
• UDI-Public: (01)00357599002008(10)01A134D
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 01/23/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 12/19/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2020
• 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